A Phase 2 interventional study of Doxorubicin Hydrochloride and Irinotecan Hydrochloride in Childhood Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma and Clear Cell Sarcoma of the Kidney, 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 2017-07-21.
Sponsored by Children's Oncology Group · Phase 2, Interventional, and Treatment
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. Evaluate whether a treatment regimen containing cyclophosphamide, carboplatin, and etoposide alternating with vincristine, doxorubicin hydrochloride, and cyclophosphamide (regimen UH-1) improves the event-free and overall survival of patients with diffuse anaplastic Wilms' tumor (DAWT) as compared to historical controls.
II. Evaluate, in a phase II "window" study, the antitumor activity of a combination of vincristine and protracted-schedule irinotecan hydrochloride in patients with metastatic DAWT.
III. Evaluate whether regimen UH-1 improves the event-free and overall survival of patients with malignant rhabdoid tumor (MRT) as compared to historical controls.
IV. Maintain the excellent event-free survival of patients with stage I clear cell sarcoma of the kidney (CCSK) without the use of abdominal irradiation.
SECONDARY OBJECTIVES:
I. Describe the outcomes of patients with stage I DAWT or stages I-III focal anaplastic Wilms' tumor (FAWT) treated with vincristine, dactinomycin, doxorubicin hydrochloride, and flank radiation.
II. Describe the outcomes of patients with stage IV FAWT or stage IV CCSK treated with regimen UH-1.
III. Describe event-free and overall survival of children and adolescents with localized renal cell carcinoma (RCC) (including patients with local lymph node involvement) treated with surgical resection without adjuvant therapy.
IV. Describe response rate, event-free survival, and overall survival of patients with unresectable or distantly metastatic RCC treated according to institutional preference.
V. Correlate histologic and molecular cytogenetic findings with outcome in pediatric RCC.
VI. Evaluate the frequency of germline and inherited INI1 mutations in renal and extrarenal MRT and correlate the presence of detectable INI1 mutation with clinical outcome.
VII. Determine the frequency of TP53 mutations in anaplastic Wilms' tumor and correlate the presence of detectable TP53 mutation with clinical outcome.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 6 treatment regimens according to tumor histology, stage of disease, and response to treatment.
SURGERY (renal cell carcinoma [RCC]): Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
REGIMEN UH-1 (stage II-III or stage IV [with no measurable disease] diffuse anaplastic Wilms' tumor [DAWT], stage I-IV malignant rhabdoid tumor [MRT], stage IV focal anaplastic Wilms' tumor [FAWT], or stage IV clear cell sarcoma of the kidney [CCSK]): Patients receive vincristine IV on day 1 in weeks 1-3, 10-12, 13-15, 22-24, and 28-30; doxorubicin hydrochloride IV over 15 minutes on day 1 and cyclophosphamide (CPM2) IV over 15-30 minutes on day 1 in weeks 1, 10, 13, 22, and 28; and cyclophosphamide (at lower doses [CPM1]) IV over 1 hour and etoposide IV over 1 hour on days 1-4 and carboplatin IV over 1 hour on day 1 in weeks 4, 7, 16, 19, and 25. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable CCSK receive no further study therapy.
IRINOTECAN/VINCRISTINE WINDOW THERAPY* (stage IV DAWT with measurable disease at diagnosis): Patients receive vincristine IV on day 1 and irinotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 2. Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.
NOTE: *Patients who are eligible for but who are unwilling to receive window therapy, receive therapy on regimen UH-1.
REGIMEN UH-2 (DAWT with CR/PR to irinotecan hydrochloride/vincristine window therapy): Patients receive vincristine on day 1 in weeks 1-3, 10, 11, 16-21, 25, 26, 28-30, and 34-36 and doxorubicin hydrochloride and CPM2 as in regimen UH-1 in weeks 1, 16, 19, 28, and 34. Patients also receive CPM1, etoposide, and carboplatin as in regimen UH-1 in weeks 4, 7, 13, 22, and 31 and irinotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 10, 11, 25, and 26. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.
REGIMEN I (stage I-III CCSK): Patients receive vincristine IV on day 1 in weeks 1-3, 5-9, 8-9, 11-14, 19, and 25; doxorubicin hydrochloride IV over 15 minutes on day 1 and cyclophosphamide IV over 1 hour on days 1-3 in weeks 1, 7, 13, 19, and 25; and cyclophosphamide IV and etoposide IV on days 1-5 in weeks 4, 10, 16, and 22. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
REGIMEN DD-4A (stage I DAWT or stages I-III FAWT): Patients receive dactinomycin IV over 1-5 minutes on day 1 in weeks 1, 7, 13, 19, and 25; vincristine IV on day 1 in weeks 1-10, 13, 16, 19, 22, and 25; and doxorubicin hydrochloride IV over 15 minutes on day 1 in weeks 4,10, 16, and 22. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 3 years.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's enrollment of 291 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell 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 disease of 1 of the following histologic types:
Renal cell carcinoma
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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 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.
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.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
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.
Patients with completely resectable stage I-IV RCC undergo surgical resection. Patients with incompletely resectable stage III-IV RCC undergo treatment as per physician's choice.
Procedure: Conventional Surgery
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, and carboplatin. Patients whose primary tumors were initially resected undergo radiotherapy once daily 5 days a week for 4-5½ weeks beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13. Patients with unresectable clear cell sarcoma of the kidney (CCSK) receive no further study therapy.
Drug: Doxorubicin Hydrochloride · Procedure: Conventional Surgery · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Carboplatin · Drug: Vincristine Sulfate · Radiation: Radiation Therapy · Other: Laboratory Biomarker Analysis
Patients receive vincristine IV on days 1 and 8 and irinotecan hydrochloride IV over 30 minutes on days 1-5 and 8-12 (course 1). Patients with progressive disease (PD) are treated with regimen UH-1. Patients with stable disease (SD), partial response (PR), or complete response (CR) receive another course of irinotecan hydrochloride/vincristine window therapy beginning on day 22. After the second course, patients with SD or PD are treated with regimen UH-1 and patients with PR or CR are treated with regimen UH-2.
Drug: Doxorubicin Hydrochloride · Drug: Irinotecan Hydrochloride · Procedure: Conventional Surgery · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Carboplatin · Drug: Vincristine Sulfate · Radiation: Radiation Therapy · Other: Laboratory Biomarker Analysis
Patients receive combination chemotherapy comprising vincristine, doxorubicin hydrochloride, cyclophosphamide, etoposide, carboplatin, and irinotecan hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 7. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 7.
Drug: Doxorubicin Hydrochloride · Drug: Irinotecan Hydrochloride · Procedure: Conventional Surgery · Drug: Etoposide · Drug: Carboplatin · Drug: Vincristine Sulfate · Radiation: Radiation Therapy · Other: Laboratory Biomarker Analysis
Patients receive vincristine, doxorubicin hydrochloride, cyclophosphamide, and etoposide. Patients whose primary tumors were initially resected (except those with stage I CCSK) undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Drug: Doxorubicin Hydrochloride · Procedure: Conventional Surgery · Drug: Cyclophosphamide · Drug: Etoposide · Drug: Vincristine Sulfate · Radiation: Radiation Therapy · Other: Laboratory Biomarker Analysis
Patients receive dactinomycin, vincristine, and doxorubicin hydrochloride. Patients whose primary tumors were initially resected undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 1. Patients with delayed primary tumor resection undergo radiotherapy as in regimen UH-1 beginning on day 1 in week 13. If the primary tumor was not previously resected, patients undergo resection, if feasible, in week 13.
Drug: Doxorubicin Hydrochloride · Procedure: Conventional Surgery · Biological: Dactinomycin · Drug: Vincristine Sulfate · Radiation: Radiation Therapy · Other: Laboratory Biomarker Analysis
Given IV
Given IV
Patients undergo resection
Also known as: surgery, conventional
Given IV
Given IV
Also known as: Lastet
Given IV
Given IV
Also known as: Lyovac Cosmegen
Given IV
Also known as: Kyocristine, Oncovin, VCR, Vincasar
Undergo radiotherapy
Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, RT
Correlative studies
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)
Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).
Time frame: 4 years
Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors
The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).
Time frame: 4 years
Response Rate
Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.
Time frame: Up to 2 months
Event Free Survival Probability
Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).
Time frame: 4 years
Toxicity Rate
Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.
Time frame: Up to 4 years
Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization
Time frame: At baseline
Frequency of TP53 Mutations
Time frame: At baseline
| Milestone | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A |
|---|---|---|---|---|---|---|
| Started | 68 | 98 | 7 | 10 | 78 | 30 |
| Completed | 66 | 64 | 2 | 5 | 77 | 29 |
| Not completed | 2 | 34 | 5 | 5 | 1 | 1 |
| Withdrew: Death | 0 | 5 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 19 | 3 | 3 | 0 | 1 |
| Withdrew: Physician decision | 0 | 6 | 2 | 1 | 0 | 0 |
| Withdrew: Ineligible | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Refusal of further protocol therapy | 0 | 4 | 0 | 1 | 0 | 0 |
Compare the outcome of patients treated with alternating CyCE/VDCy chemotherapy (with or without vincristine/irinotecan cycles) to a fixed outcome based on that seen for similar patients treated with NWTS-5 (NCT00002610).
| Percentage of 4-year OS | UH-1 | Window/UH-1 | UH-2 |
|---|---|---|---|
| Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT) | 76.1 (62.5 to 89.6) | 25.0 (0 to 67.4) | 87.5 (64.6 to 100.0) |
The outcome of these patients will be compared with a fixed outcome based on that seen for similar patients treated with NWTS-5 regimen (NCT00002610).
| Percentage of 4-year OS | UH-1 |
|---|---|
| Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors | 38.9 (20.1 to 57.7) |
Criteria for response assessed by three-dimensional measurement: Complete Response (CR), Disappearance of all index lesions and non-index lesions. No new lesions; Partial Response (PR), At least a 65% decrease in the sum of the volumes of the index lesions. No new lesions; Response rate (RR) = CR+PR of patients who received window therapy.
| Percentage of participants | Combined Window/UH-1 and UH-2 |
|---|---|
| Response Rate | 71 (49 to 92) |
Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).
| Percent Probability 4 Year EFS | Regimen DD-4A |
|---|---|
| Event Free Survival Probability | 100.0 (100.0 to 100.0) |
Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.
| Percentage of patients | Combined UH-2, UH-1, Window/UH-1 |
|---|---|
| Cardiac toxicities | 4.9 (0 to 10.3) |
| Treatment-related deaths | 4.9 (0 to 10.3) |
| Sinusoidal Obstruction Syndrome | 0 (0 to 0) |
| Count participants | UH-1 | Window/UH-1 |
|---|---|---|
| Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization | 23 | 1 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Surgery | — | 2/66 (3%) | 0/66 (0%) |
| UH-1 | — | 19/98 (19.4%) | 81/98 (82.7%) |
| Window/UH-1 | — | 3/7 (42.9%) | 5/7 (71.4%) |
| UH-2 | — | 0/10 (0%) | 9/10 (90%) |
| Regimen I | — | 3/78 (3.8%) | 7/78 (9%) |
| Regimen DD-4A | — | 1/30 (3.3%) | 1/30 (3.3%) |
| Event | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A |
|---|---|---|---|---|---|---|
| 24600-Death NOSGeneral disorders | 0/66 | 5/98 | 2/7 | 0/10 | 2/78 | 1/30 |
| 10300-Abdominal painGastrointestinal disorders | 0/66 | 0/98 | 1/7 | 0/10 | 0/78 | 0/30 |
| 17400-Blood bilirubin increasedInvestigations | 0/66 | 2/98 | 1/7 | 0/10 | 0/78 | 0/30 |
| 55700-Multi-organ failureGeneral disorders | 0/66 | 0/98 | 1/7 | 0/10 | 0/78 | 0/30 |
| 88200-Weight gainInvestigations | 0/66 | 0/98 | 1/7 | 0/10 | 0/78 | 0/30 |
| 11300-Adult respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/66 | 2/98 | 0/7 | 0/10 | 0/78 | 0/30 |
| 14900-AscitesGastrointestinal disorders | 0/66 | 2/98 | 0/7 | 0/10 | 0/78 | 0/30 |
| 43900-HypoxiaRespiratory, thoracic and mediastinal disorders | 0/66 | 2/98 | 0/7 | 0/10 | 0/78 | 0/30 |
| 66300-PneumonitisRespiratory, thoracic and mediastinal disorders | 0/66 | 2/98 | 0/7 | 0/10 | 0/78 | 0/30 |
| 71500-Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/66 | 2/98 | 0/7 | 0/10 | 0/78 | 0/30 |
| Event | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A |
|---|---|---|---|---|---|---|
| 33300-Febrile neutropeniaBlood and lymphatic system disorders | 0/66 | 56/98 | 3/7 | 8/10 | 4/78 | 0/30 |
| 44800-Infections and infestations - Other specifyInfections and infestations | 0/66 | 44/98 | 4/7 | 4/10 | 1/78 | 0/30 |
| 43100-HypokalemiaMetabolism and nutrition disorders | 0/66 | 14/98 | 3/7 | 1/10 | 0/78 | 0/30 |
| 25700-DiarrheaGastrointestinal disorders | 0/66 | 10/98 | 1/7 | 3/10 | 0/78 | 0/30 |
| 10100-Abdominal distensionGastrointestinal disorders | 0/66 | 0/98 | 2/7 | 0/10 | 0/78 | 0/30 |
| 13500-AnorexiaMetabolism and nutrition disorders | 0/66 | 20/98 | 2/7 | 2/10 | 3/78 | 0/30 |
| 42600-HypoalbuminemiaMetabolism and nutrition disorders | 0/66 | 4/98 | 2/7 | 1/10 | 0/78 | 0/30 |
| 43900-HypoxiaRespiratory, thoracic and mediastinal disorders | 0/66 | 6/98 | 2/7 | 1/10 | 0/78 | 0/30 |
| 87900-VomitingGastrointestinal disorders | 0/66 | 9/98 | 2/7 | 1/10 | 1/78 | 0/30 |
| 24700-DehydrationMetabolism and nutrition disorders | 0/66 | 9/98 | 0/7 | 2/10 | 0/78 | 0/30 |
| Age, Continuous(Months) | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A | Total |
|---|---|---|---|---|---|---|---|
| Mean | 148.53 ± 51.74 | 52.39 ± 40.09 | 68.95 ± 97.64 | 54.04 ± 19.71 | 34.10 ± 31.10 | 54.29 ± 32.72 | 70.60 ± 60.50 |
| Sex: Female, Male(Participants) | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A | Total |
|---|---|---|---|---|---|---|---|
| Female | 28 | 55 | 5 | 7 | 31 | 11 | 137 |
| Male | 40 | 43 | 2 | 3 | 47 | 19 | 154 |
| Ethnicity (NIH/OMB)(Participants) | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 8 | 0 | 2 | 15 | 4 | 34 |
| Not Hispanic or Latino | 63 | 88 | 6 | 8 | 63 | 25 | 253 |
| Unknown or Not Reported | 0 | 2 | 1 | 0 | 0 | 1 | 4 |
| Race (NIH/OMB)(Participants) | Surgery | UH-1 | Window/UH-1 | UH-2 | Regimen I | Regimen DD-4A | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 0 | 3 | 0 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Black or African American | 22 | 17 | 1 | 2 | 13 | 5 | 60 |
| White | 40 | 72 | 5 | 8 | 55 | 22 | 202 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 8 | 1 | 0 | 7 | 3 | 23 |
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Studies of the drugs tested here: Doxorubicin · Irinotecan · Cyclophosphamide · Etoposide · Carboplatin · Dactinomycin · Vincristine