Trial · NCT00335556

Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors

NCT00335556, Phase 2, Completed, Children's Oncology Group; results first posted 2017-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors. Trials, record NCT00335556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00335556

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
NCT number: NCT00335556
Status: Completed
Phases: Phase 2
Enrollment: 291 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Childhood Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Clear Cell Sarcoma of the Kidney, Papillary Renal Cell Carcinoma, Rhabdoid Tumor of the Kidney, Stage I Renal Cell Cancer, Stage I Renal Wilms Tumor, Stage II Renal Cell Cancer, Stage II Renal Wilms Tumor, Stage III Renal Cell Cancer, Stage III Renal Wilms Tumor, Stage IV Renal Cell Cancer, Stage IV Renal Wilms Tumor
Interventions: Doxorubicin Hydrochloride, Irinotecan Hydrochloride, Conventional Surgery, Cyclophosphamide, Etoposide, Carboplatin, Dactinomycin, Vincristine Sulfate, Radiation Therapy, Laboratory Biomarker Analysis
First posted: 2006-06-12
Last updated: 2017-07-21
Results first posted: 2017-06-14

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)	4 years	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).
Primary	Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors	4 years	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).
Primary	Response Rate	Up to 2 months	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.
Primary	Event Free Survival Probability	4 years	Event-free survival will be informally compared to that seem for similar patients treated on NWTS-5 (NCT00002610).
Primary	Toxicity Rate	Up to 4 years	Percentage of participants with Grade 4 cardiac toxicities, Grade 4 Sinusoidal Obstruction Syndrome (SOS), and treatment-related deaths determined using CTCAE v4.
Secondary	Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization	At baseline
Secondary	Frequency of TP53 Mutations	At baseline

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)	4 years	Eligible patients with Stage II-IV DAWT.	Percentage of 4-year OS	NUMBER
PRIMARY	Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors	4 years	Eligible patients with Stage I-IV rhabdoid tumor.	Percentage of 4-year OS	NUMBER
PRIMARY	Response Rate	Up to 2 months		Percentage of participants	NUMBER
PRIMARY	Event Free Survival Probability	4 years	Eligible patients with Stage I focal and diffuse anaplastic Wilms tumor.	Percent Probability 4 Year EFS	NUMBER
PRIMARY	Toxicity Rate	Up to 4 years	Eligible patients treated after Amendment 3A for arms UH-1, UH-2, and Window/UH-1.	Percentage of patients	NUMBER
SECONDARY	Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization	At baseline	Eligible patients with reported INI1 mutation data.	Count participants	NUMBER
SECONDARY	Frequency of TP53 Mutations	At baseline	The analysis was supplanted by an analysis done as part of the TARGET initiative on NWTS-5 sample as a result no TP53 data was collected on AREN0321.

Source ClinicalTrials.gov

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)	UH-1		76.1	95% Confidence Interval 62.5 to 89.6	Percentage of 4-year OS
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)	Window/UH-1		25.0	95% Confidence Interval 0 to 67.4	Percentage of 4-year OS
Event-Free Survival of Patients With Diffuse Anaplastic Wilms' Tumor (DAWT)	UH-2		87.5	95% Confidence Interval 64.6 to 100.0	Percentage of 4-year OS
Long-term Survival of Patients With Stage I-IV Malignant Rhabdoid Tumors	UH-1		38.9	95% Confidence Interval 20.1 to 57.7	Percentage of 4-year OS
Response Rate	Combined Window/UH-1 and UH-2		71	95% Confidence Interval 49 to 92	Percentage of participants
Event Free Survival Probability	Regimen DD-4A		100.0	95% Confidence Interval 100.0 to 100.0	Percent Probability 4 Year EFS
Toxicity Rate	Combined UH-2, UH-1, Window/UH-1	Cardiac toxicities	4.9	95% Confidence Interval 0 to 10.3	Percentage of patients
Toxicity Rate	Combined UH-2, UH-1, Window/UH-1	Treatment-related deaths	4.9	95% Confidence Interval 0 to 10.3	Percentage of patients
Toxicity Rate	Combined UH-2, UH-1, Window/UH-1	Sinusoidal Obstruction Syndrome	0	95% Confidence Interval 0 to 0	Percentage of patients
Number of Patients With INI1 Mutations in Renal and Extrarenal Malignant Rhabdoid Tumor by Fluorescent in Situ Hybridization	UH-1		23		Count participants

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Surgery	68
Overall Study	STARTED	UH-1	98
Overall Study	STARTED	Window/UH-1	7
Overall Study	STARTED	UH-2	10
Overall Study	STARTED	Regimen I	78
Overall Study	STARTED	Regimen DD-4A	30
Overall Study	COMPLETED	Surgery	66
Overall Study	COMPLETED	UH-1	64
Overall Study	COMPLETED	Window/UH-1	2
Overall Study	COMPLETED	UH-2	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events954

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	10100-Abdominal distension	Gastrointestinal disorders	Surgery	0	66	0
other	10100-Abdominal distension	Gastrointestinal disorders	UH-1	0	98	0
other	10100-Abdominal distension	Gastrointestinal disorders	Window/UH-1	2	7	2
other	10100-Abdominal distension	Gastrointestinal disorders	UH-2	0	10	0
other	10100-Abdominal distension	Gastrointestinal disorders	Regimen I	0	78	0
other	10100-Abdominal distension	Gastrointestinal disorders	Regimen DD-4A	0	30	0
other	10200-Abdominal infection	Infections and infestations	Surgery	0	66	0
other	10200-Abdominal infection	Infections and infestations	UH-1	0	98	0
other	10200-Abdominal infection	Infections and infestations	Window/UH-1	0	7	0
other	10200-Abdominal infection	Infections and infestations	UH-2	1	10	1

1 to 10 of 954Source ClinicalTrials.gov

See all 954 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Surgery
Total, all-cause mortality	UH-1
Total, all-cause mortality	Window/UH-1
Total, all-cause mortality	UH-2
Total, all-cause mortality	Regimen I
Total, all-cause mortality	Regimen DD-4A
Total, other adverse events	Surgery	0	66
Total, other adverse events	UH-1	81	98
Total, other adverse events	Window/UH-1	5	7
Total, other adverse events	UH-2	9	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38396300	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00335556

GET https://conductscience.org/api/trials/v1/NCT00335556/events?page=2

API reference For AI assistants