A Phase 2 interventional study of 3-Dimensional Conformal Proton Radiation Therapy and 3-Dimensional Conformal Radiation Therapy in Basal Ganglia Germinoma, Diabetes Insipidus and Germinoma, sponsored by Children's Oncology Group. Recruiting at 115 sites in 3 countries. Open to participants aged 3 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Children's Oncology Group · Phase 2, Interventional, and Treatment
This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.
PRIMARY OBJECTIVE:
I. To determine whether 12 Gy whole ventricular irradiation (WVI) and 12 Gy tumor boost would maintain similar efficacy compared to ACNS1123 stratum 2 as measured by event-free survival (EFS) in eligible patients with localized primary central nervous system (CNS) germinoma who present with serum and/or cerebrospinal fluid (CSF) human chorionic gonadotropin-beta (hCGbeta) ≤ 100 IU/L and normal alpha-fetoprotein (AFP), and meet complete response (CR) or continued complete response (CCR) criteria following chemotherapy/second-look surgery (Stratum 1).
SECONDARY OBJECTIVES:
I. To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with partial response (PR) after chemotherapy, followed by 18 Gy WVI and 12 Gy tumor boost (Stratum 2).
II. To estimate the EFS distribution for patients with localized midline - including bifocal - CNS germinoma with less than a PR after chemotherapy, followed by 24 Gy WVI and 12 Gy tumor boost (Stratum 3).
III. To estimate the overall survival (OS), response rates to chemotherapy and radiotherapy (RT), as well as the patterns of failure of the various cohorts based on tumor characteristics, treatment regimen, and treatment modality.
IV. To determine the impact of tumor characteristics, treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas.
V. To prospectively evaluate processing speed of children and young adults with CNS germinoma through the Children's Oncology Group (COG) Standardized assessment battery.
EXPLORATORY OBJECTIVES:
I. To estimate the EFS distribution for patients with metastatic germinomas treated with chemotherapy followed by craniospinal irradiation (CSI) [18 Gy for CR/CCR (Stratum 4)] or [24 Gy for less than CR (Stratum 5)] with a 12 Gy tumor boost to the pre-treatment volume, including metastatic sites.
II. To estimate the EFS distribution for patients with basal ganglia and thalamic germinomas (BGTG) treated with chemotherapy followed by whole brain irradiation (WBI) [18 Gy for CR/CCR (Stratum 6)] or [24 Gy for less than CR (Stratum 7)] with a 12 Gy tumor boost to the pre-treatment volume.
III. To prospectively collect blood, cerebrospinal fluid, and tumor tissue at diagnosis and second-look surgery (if feasible) for future biology studies.
IV. To prospectively measure the incidence of cerebral vascular events (stroke or transient ischemic attacks) in the follow-up period and longitudinally evaluate and model the cognitive, social and behavioral functioning of children and young adults with CNS germinoma through the COG Standardized assessment battery, and compare these outcomes based on tumor characteristics, treatment regimen, and treatment modality.
OUTLINE:
INDUCTION PHASE: All patients receive carboplatin intravenously (IV) over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Patients are then assigned to 1 of 7 strata.
STRATUM I: Patients with localized germinoma achieving CR with normalization of markers undergo 3-dimensional conformal radiation therapy (3D-CRT)/3-dimensional conformal proton radiation therapy (3D-CPRT) or intensity-modulated radiation therapy (IMRT)/intensity modulated proton therapy (IMPT) once daily (QD) 5 days a week for 16 days. Patients achieving PR with normalization of markers may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 16 days. Patients with normalization of markers who fail to achieve CR or PR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 16 days. Patients with bifocal germinoma undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 16 days.
STRATUM II: Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days.
STRATUM III: Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days.
STRATUM IV: Patients with metastatic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days.
STRATUM V: Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days.
STRATUM VI: Patients with basal ganglia and thalamic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days.
STRATUM VII: Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days.
Patients with non-normalized tumor markers or PD and no second-look surgery or viable tumor during second-look surgery discontinue protocol therapy.
All patients undergo magnetic resonance imaging (MRI) and optional blood and tissue sample collection throughout the study. Patients may undergo lumbar puncture (LP) for CSF sample collection during screening and follow up.
After completion of study treatment, patients are followed up every 3 months for 12 months, every 4 months for 24 months, and then annually for up to 120 months.
191 studies on the registry are indexed under Diabetes Insipidus; 35 are open to participants now.
This study's planned enrollment of 240 is above the median of 75 across 118 interventional studies indexed under Diabetes Insipidus.
Browse Diabetes Insipidus studies →Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For pediatric patients (age 3-17 years): A serum creatinine based on age/sex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated):
For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated):
Serum glutamic-pyruvic transaminase () (alanine transaminase [ALT]) ≤ 135 U/L (Must be performed within 7 days prior to enrollment unless otherwise indicated)
Exclusion Criteria:
Patients with any of the following malignant pathological elements are not eligible:
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
See Detailed Description.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration · Procedure: Surgical Procedure
Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma achieving PR with normalization of markers who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with localized germinoma with normalization of markers who fail to achieve CR or PR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with metastatic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration · Procedure: Surgical Procedure
Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with metastatic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration
Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma achieving CR undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients with basal ganglia and thalamic germinoma and normalization of markers who fail to achieve CR may undergo second-look surgery. Patients found to have mature teratoma or non-viable tumor undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 20 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration · Procedure: Surgical Procedure
Patients receive carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 90-120 minutes on days 1-3 of each cycle. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with basal ganglia and thalamic germinoma with normalization of markers who fail to achieve CR who do not undergo second-look surgery undergo 3D-CRT/3D-CPRT or IMRT/IMPT QD 5 days a week for 24 days. Patients undergo MRI and optional blood and tissue sample collection throughout the study. Patients may undergo LP for CSF sample collection during screening and follow up.
Radiation: 3-Dimensional Conformal Proton Radiation Therapy · Radiation: 3-Dimensional Conformal Radiation Therapy · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Etoposide · Procedure: Intensity-Modulated Proton Therapy · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Lumbar Puncture · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration
Undergo 3D-CPRT
Also known as: 3D-CPRT
Undergo 3D-CRT
Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)
Undergo blood and CSF sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given IV
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Given IV
Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213
Undergo IMPT
Also known as: IMPT
Undergo IMRT
Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Undergo LP
Also known as: LP, Spinal Tap
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Ancillary studies
Undergo second-look surgery
Also known as: Operation, Surgery, Surgery Type, Surgery, NOS, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery
Event-free survival (EFS) (Stratum I)
Will be estimated for eligible and evaluable patients assigned to Stratum 1 using Kaplan-Meier (KM) EFS estimates at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
Time frame: Evaluated at 2- and 3-years post-radiation initiation
EFS (Stratum II)
Will be estimated for eligible and evaluable patients assigned to Stratum 2 using KM methods at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
Time frame: Evaluated at 2- and 3-years post-radiation initiation
EFS (Stratum III)
Will be estimated for eligible and evaluable patients assigned to Stratum 3 using KM methods at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
Time frame: Evaluated at 2- and 3-years post-radiation initiation
Radiographic response rate
Will report the response rates using the respective sample proportions and exact binomial two-sided 95% confidence intervals.
Time frame: Following the completion of Induction therapy, approximately 12 weeks post-chemotherapy initiation
Marker tumor response rate
Will report the response rates using the respective sample proportions and exact binomial two-sided 95% confidence intervals.
Time frame: Following the completion of Induction therapy, approximately 12 weeks post-chemotherapy initiation
Overall survival (OS)
Will use KM methods to estimate stratum-specific OS.
Time frame: Time from initiation of radiation therapy until death by any cause, up to 10 years post-enrollment
Neuroendocrine dysfunction (including growth hormone deficiency)
Will be summarized by the Kalbfleisch-Prentice cumulative incidence function approach, separately by stratum and by neuroendocrine dysfunction event. Competing risks will include disease progression and death, and patients without events or competing risks will be censored at the time of their last follow-up.
Time frame: Time from initiation of radiation treatment until date of diagnosis of neuroendocrine dysfunction event, up to 10 years post-enrollment
Processing speed
Will be assessed by processing speed index tasks for the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition, Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) depending on age. The mean processing speed at 30-months post-diagnosis in ACNS2321 Stratum 1 patients will be compared to the respective mean in ACNS1123 Stratum 2 patients who had a complete response/continued complete response and received 18 grey (Gy) whole ventricle irradiation + 12 Gy boost to primary site.
Time frame: At 9 months (+/- 3 months), 30 months (+/- 3 months), and 60 months (+/- 3 months) after diagnosis
EFS (Stratum IV and Stratum V)
Will be estimated separately for eligible and evaluable patients assigned to Stratum 4 and 5 using KM methods at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
Time frame: Evaluated at 2- and 3-years post-radiation initiation
EFS (Stratum VI and Stratum VII)
Will be estimated separately for eligible and evaluable patients assigned to Stratum 6 and 7 using KM methods at 2 and 3 years with respective 80% two-sided confidence intervals. Time from initiation of radiation to the first occurrence of any of the following events: biochemical or radiographic disease progression, disease recurrence, second malignant neoplasm, or death from any cause.
Time frame: Evaluated at 2- and 3-years post-radiation initiation
Incidence of cerebral vascular events (stroke or transient ischemic attacks)
Will be reported as the number of cerebral vascular events.
Time frame: Up to 10 years post-enrollment
Working memory
Will be assessed by Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span subtest depending on age. Mean scores over time will be computed for each stratum.
Time frame: At 9 months (+/- 3 months), 30 months (+/- 3 months), and 60 months (+/- 3 months) after diagnosis
Verbal learning
Will be assessed by California Verbal Learning Test - Children's Version for 5 years through 17 years or California Verbal Learning Test - Third for ages 17 and up depending on age. Mean scores over time will be computed for each stratum.
Time frame: At 9 months (+/- 3 months), 30 months (+/- 3 months), and 60 months (+/- 3 months) after diagnosis
Patient-reported outcome measures of executive function
Will be assessed by the Behavioral Rating Inventory of Executive Function (BRIEF-2 and BRIEF-A) depending on patient's age. Mean scores over time will be computed for each stratum.
Time frame: At 9 months (+/- 3 months), 30 months (+/- 3 months), and 60 months (+/- 3 months) after diagnosis
Health-reported quality of life
Will be assessed by the PedsQL 4.0 Generic Module. Mean scores over time will be computed for each stratum.
Time frame: At 9 months (+/- 3 months), 30 months (+/- 3 months), and 60 months (+/- 3 months) after diagnosis
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