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

NCT00335556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2017-07-21

Study results available
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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.

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

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

PROCEDURE

Conventional Surgery

Patients undergo resection

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

DRUG

Carboplatin

Given IV

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Vincristine Sulfate

Given IV

RADIATION

Radiation Therapy

Undergo radiotherapy

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Jeffrey Dome, MD · Children's Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2015-12-31

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00335556 on ClinicalTrials.gov