A Phase 3 interventional study of doxorubicin hydrochloride and clinical observation in Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma and Adult Epithelioid Sarcoma, sponsored by Children's Oncology Group. Completed at 187 sites in 5 countries. Open to participants aged Up to 29 Years. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Children's Oncology Group · Phase 3, Interventional, and Treatment
This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PRIMARY OBJECTIVES:
I. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).
II. Assess event-free and overall survival of patients treated with these regimens.
III. Assess the pattern of treatment failure in these patients.
SECONDARY OBJECTIVES:
I. Assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- or high-risk NRSTS.
II. Assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in patients with intermediate- or high-risk NRSTS.
III. Correlate imaging and pathologic response with clinical outcomes in patients with intermediate- or high-risk disease who undergo neoadjuvant chemoradiotherapy.
IV. Prospectively define clinical prognostic factors associated with event-free survival, overall survival, local recurrence, and distant recurrence in these patients.
V. Correlate patient outcomes with findings of biologic studies performed on tissue specimens collected on protocol COG-D9902 from these patients.
VI. Determine whether the diagnosis and histologic grade of NRSTS assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology reviewers.
VII. Compare the Pediatric Oncology Group (POG) and Fédération Nationale des Centres de Lutte Contre le Cancer (French Federation of Cancer Centers [FNCLCC]) pathologic grading systems to determine which better correlates with clinical outcomes.
OUTLINE: This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs no), status of prior surgery (resected vs unresected), grade of tumor (low vs high), and size of primary tumor (≤ 5 cm vs > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs metastatic), tumor size (≤ 5 cm vs > 5 cm), extent of resection of primary tumor (resected vs unresected), extent of resection of metastases (complete or microscopic residual vs gross residual), microscopic tumor margins (negative vs positive), and tumor grade (low vs high).
GROUP 1 (low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to regimen A. Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to regimen B.
REGIMEN A (observation only): Patients undergo observation only.
REGIMEN B (adjuvant radiotherapy): Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
GROUP 2 (intermediate risk [nonmetastatic, resected or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to regimen C. Patients with unresected tumor are assigned to regimen D.
REGIMEN C (adjuvant chemoradiotherapy): Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, 10, 13, and 16 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1, 4, 13, 16, and 19. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
*NOTE: *Patients who receive brachytherapy will initiate radiotherapy in Week 1. If brachytherapy is administered, chemotherapy should begin within 2 weeks of completion of brachytherapy and the Weeks 1 and 19 doxorubicin should be given instead at Weeks 7 and 10.
REGIMEN D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Neoadjuvant chemoradiotherapy and surgery: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, and 10 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1 and 4. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy**. Patients undergo surgical resection in week 13.
NOTE: **Patients with primary hepatic tumors do not receive radiotherapy in week 4.
Adjuvant chemotherapy with or without radiotherapy: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 16 and 19 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 16, 19***, and 22. Beginning in week 16, patients achieving gross total resection with positive microscopic margins undergo a total of 6 fractions of adjuvant radiotherapy. Patients achieving less than total gross resection undergo a total of 11 fractions of adjuvant radiotherapy. Patients achieving total gross resection with negative microscopic margins do not receive adjuvant radiotherapy.
NOTE: ***Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19.
GROUP 3 (high risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, and metastatic disease are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D.
In all groups, treatment continues in the absence of disease progression. After completing study treatment, patients are followed periodically for at least 5 years.
51 studies on the registry are indexed under Sarcoma, Alveolar Soft Part; 10 are open to participants now.
This study's enrollment of 588 is above the median of 53 across 49 interventional studies indexed under Sarcoma, Alveolar Soft Part.
Browse Sarcoma, Alveolar Soft Part 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.
Inclusion Criteria:
Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
Meets 1 of the following criteria:
Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:
Adipocytic tumor, including liposarcoma of any of the following histology subtypes:
Fibroblastic/myofibroblastic tumors, including any of the following:
So-called fibrohistiocytic tumors, including any of the following:
Chondro-osseous tumors of any of the following types:
Tumors of uncertain differentiation, including any of the following:
Dermatofibrosarcoma protuberans meeting both of the following criteria:
Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:
High-grade tumor with metastases
Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node or lymph node sampling to confirm the status of regional lymph nodes* NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement.
or radioisotope ≥ 70 mL/min (≥ 40 mL/min for infants \< 1 year of age)* or serum creatinine based on age and/or gender as follows:
Not pregnant or nursing (patients undergoing radiotherapy and/or chemotherapy)
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 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 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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
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.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).
Other: clinical observation · Procedure: therapeutic conventional surgery
Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
Other: clinical observation · Procedure: therapeutic conventional surgery · Radiation: 3-dimensional conformal radiation therapy
High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
Drug: doxorubicin hydrochloride · Other: clinical observation · Radiation: 3-dimensional conformal radiation therapy · Drug: ifosfamide
High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
Drug: doxorubicin hydrochloride · Other: clinical observation · Procedure: therapeutic conventional surgery · Radiation: 3-dimensional conformal radiation therapy · Drug: ifosfamide
Given IV
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Patients undergo observation
Also known as: observation
Patients undergo surgery
Patients undergo radiotherapy
Also known as: 3D conformal radiation therapy, 3D-CRT
Given IV
Also known as: Cyfos, Holoxan, IFF, IFX, IPP
Probability for Event Free Survival.
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Time frame: 5 years
Toxicity Rate
Percentage of Arm D patients experiencing grade 4+ adverse events.
Time frame: 13 weeks
Complete or Partial Response Rate
Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.
Time frame: 13 weeks
Percent Tumor Necrosis
Percent tumor necrosis by pathology review.
Time frame: 13 weeks
Event Free Survival Probability Disease Extent
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
Time frame: 5 years
Event Free Survival Probability Histologic Grade
Probability of no relapse, secondary malignancy or death after 5 years since enrollment
Time frame: 5 years
Overall Survival Probability Disease Extent
Probability of survival after 5 years since enrollment.
Time frame: 5 years
Overall Survival Probability Extent of Resection of the Primary Tumor
Probability of survival after 5 years since enrollment.
Time frame: 5 years
Incidence of Distant Metastasis
Percent of patients who had distant metastasis.
Time frame: Up to 10 years
Genetic and Gene Expression Profiles
The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.
Time frame: At diagnosis
Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers
Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.
Time frame: At Diagnosis
Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems
POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.
Time frame: At diagnosis
| Milestone | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy |
|---|---|---|---|---|
| Started | 222 | 21 | 122 | 223 |
| Completed | 205 | 14 | 96 | 117 |
| Not completed | 17 | 7 | 26 | 106 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 | 7 | 25 |
| Withdrew: Physician decision | 0 | 1 | 2 | 27 |
| Withdrew: Protocol violation | 6 | 2 | 10 | 4 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 0 |
| Withdrew: Ineligible | 11 | 2 | 2 | 23 |
| Withdrew: Refusal of further protocol therapy | 0 | 1 | 3 | 15 |
| Withdrew: Inability to start week 16 tx on time | 0 | 0 | 0 | 11 |
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
| Probability of EFS at 5 years | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy |
|---|---|---|---|---|
| Probability for Event Free Survival. | 0.8984 (0.8395 to 0.9572) | 0.7647 (0.5348 to 0.9946) | 0.6079 (0.4818 to 0.7341) | 0.4873 (0.3951 to 0.5796) |
Percentage of Arm D patients experiencing grade 4+ adverse events.
| percentage of participants | Arm D |
|---|---|
| Toxicity Rate | 3.06 (0.65 to 5.47) |
Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.
| percentage of patients | Arm D |
|---|---|
| Complete or Partial Response Rate | 33.1 (25.36 to 40.84) |
Percent tumor necrosis by pathology review.
| percentage of tumor necrosis | Arm D |
|---|---|
| Percent Tumor Necrosis | 59.4 ± 38.5 |
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
| Probability | Non-metastatic | Metastatic |
|---|---|---|
| Event Free Survival Probability Disease Extent | 0.7758 (0.7202 to 0.8313) | 0.1960 (0.0742 to 0.3178) |
Probability of no relapse, secondary malignancy or death after 5 years since enrollment
| Probability | Histologic Grade 1 | Histologic Grade 2 | Histologic Grade 3 |
|---|---|---|---|
| Event Free Survival Probability Histologic Grade | 0.9636 (0.8943 to 1.0000) | 0.8505 (0.7382 to 0.9627) | 0.6136 (0.5442 to 0.6831) |
Probability of survival after 5 years since enrollment.
| Probability | Non-metastatic | Metastatic |
|---|---|---|
| Overall Survival Probability Disease Extent | 0.8752 (0.8313 to 0.9190) | 0.3153 (0.1677 to 0.4629) |
Probability of survival after 5 years since enrollment.
| Probability | Less Than Total Resection | Negative Margins | Positive Margins |
|---|---|---|---|
| Overall Survival Probability Extent of Resection of the Primary Tumor | 0.5975 (0.4913 to 0.7036) | 0.9353 (0.8923 to 0.9782) | 0.7764 (0.6565 to 0.8963) |
Percent of patients who had distant metastasis.
| Percentage of participants | Non-metastatic | Metastatic |
|---|---|---|
| Incidence of Distant Metastasis | 10.59 (7.66 to 13.51) | 60.87 (49.35 to 72.39) |
Percent of patients who had distant metastasis.
| Percentage of participants | Histologic Grade 1 | Histologic Grade 2 | Histologic Grade 3 |
|---|---|---|---|
| Incidence of Distant Metastasis | 0.00 (0.00 to NA) | 5.06 (0.23 to 9.90) | 23.38 (18.98 to 27.78) |
The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.
No measurements were reported for this outcome.
Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.
| Participants | Histologic Grade 1 by Enrolling Institution | Histologic Grade 2 by Enrolling Institution | Histologic Grade 3 by Enrolling Institution |
|---|---|---|---|
| Histologic grade 1 by central pathology reviewers | 38 | 5 | 1 |
| Histologic grade 2 by central pathology reviewers | 4 | 56 | 9 |
| Histologic grade 3 by central pathology reviewers | 3 | 10 | 268 |
POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.
| Participants | Histologic Grade 1 by FNCLCC | Histologic Grade 2 by FNCLCC | Histologic Grade 3 by FNCLCC |
|---|---|---|---|
| Histologic grade 1 by POG | 46 | 8 | 1 |
| Histologic grade 2 by POG | 24 | 69 | 0 |
| Histologic grade 3 by POG | 9 | 145 | 240 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: No Adjuvant Treatment | — | 0/205 (0%) | 0/205 (0%) |
| Arm B: Low Risk; Adjuvant Radiotherapy | — | 1/17 (5.9%) | 0/17 (0%) |
| Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | — | 1/110 (0.9%) | 2/110 (1.8%) |
| Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy | — | 3/196 (1.5%) | 7/196 (3.6%) |
| Event | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy |
|---|---|---|---|---|
| Treatment related secondary malignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/205 | 1/17 | 0/110 | 0/196 |
| Upper gastrointestinal hemorrhageGastrointestinal disorders | 0/205 | 0/17 | 1/110 | 0/196 |
| Death NOSGeneral disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| Infections and infestations - Other, specifyInfections and infestations | 0/205 | 0/17 | 0/110 | 1/196 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/205 | 0/17 | 0/110 | 1/196 |
| Event | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy |
|---|---|---|---|---|
| EncephalopathyNervous system disorders | 0/205 | 0/17 | 1/110 | 1/196 |
| HypotensionVascular disorders | 0/205 | 0/17 | 1/110 | 1/196 |
| Cardiac disorders - Other, specifyCardiac disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| Dermatitis radiationInjury, poisoning and procedural complications | 0/205 | 0/17 | 0/110 | 1/196 |
| DiarrheaGastrointestinal disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| General disorders and administration site conditions - Other, specifyGeneral disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| Hepatic infectionInfections and infestations | 0/205 | 0/17 | 0/110 | 1/196 |
| HypokalemiaMetabolism and nutrition disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| Pericardial effusionCardiac disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| SeizureNervous system disorders | 0/205 | 0/17 | 0/110 | 1/196 |
| Age, Continuous(Months) | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy | Total |
|---|---|---|---|---|---|
| Mean | 138.87 ± 60.88 | 142.58 ± 59.46 | 155.14 ± 69.20 | 171.31 ± 68.90 | 154.68 ± 67.10 |
| Sex: Female, Male(Participants) | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy | Total |
|---|---|---|---|---|---|
| Female | 124 | 9 | 60 | 120 | 313 |
| Male | 98 | 12 | 62 | 103 | 275 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 29 | 1 | 22 | 38 | 90 |
| Not Hispanic or Latino | 185 | 19 | 95 | 178 | 477 |
| Unknown or Not Reported | 8 | 1 | 5 | 7 | 21 |
| Race (NIH/OMB)(Participants) | Arm A: No Adjuvant Treatment | Arm B: Low Risk; Adjuvant Radiotherapy | Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy | Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 2 | 3 | 6 |
| Asian | 7 | 1 | 2 | 8 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 1 |
| Black or African American | 23 | 2 | 21 | 43 | 89 |
| White | 169 | 16 | 90 | 137 | 412 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 22 | 2 | 7 | 31 | 62 |
Showing the first 100 of 187 sites across 5 countries. Choose a country and city above to see the rest.
Ran from Feb 2007 to primary completion in Sep 2014, 91 months.
Results were first posted in Oct 2017, 3 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxorubicin · Ifosfamide