CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 291 enrolled
Drug / intervention
Doxorubicin Hydrochloride +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00335556
NCT00335556Phase 2Completed
CompareCT.gov

Treatment of High Risk Renal Tumors: A Groupwide Phase II Study

Children's Oncology Group·interventional·Posted Jun 12, 2006·Updated Jul 21, 2017

In Brief

A Phase 2 clinical trial evaluating Doxorubicin Hydrochloride, Irinotecan Hydrochloride, and 8 other interventions for Childhood Renal Cell Carcinoma and 12 related conditions. Completed, enrolled 291 participants across 187 sites in 5 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood 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
CountriesAustralia, Canada, New Zealand, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 20.1 years ago

Interventions

Doxorubicin Hydrochloridedrug

Given IV

Irinotecan Hydrochloridedrug

Given IV

Conventional Surgeryprocedure

Patients undergo resection

Cyclophosphamidedrug

Given IV

Etoposidedrug

Given IV

Carboplatindrug

Given IV

Dactinomycinbiological

Given IV

Vincristine Sulfatedrug

Given IV

Radiation Therapyradiation

Undergo radiotherapy

Laboratory Biomarker Analysisother

Correlative studies