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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002611 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. It is not yet known whether combination chemotherapy alone or combination chemotherapy plus radiation therapy is more effective for childhood kidney cancer.
PURPOSE: Phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating children who have kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Biological: dactinomycin Biological: filgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | NATIONAL WILMS TUMOR STUDY-5 -- THERAPEUTIC TRIAL AND BIOLOGY STUDY |
Ages Eligible for Study: | up to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage I-V kidney cancer of one of the following histologies:
Rhabdoid tumor
Prior nephrectomy or biopsy required
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Daniel M. Green, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000063901, COG-Q9401, NWTS-Q9401, CCG-4941, POG-9440, INT-0150, NWTS-5 |
Study First Received: | November 1, 1999 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00002611 History of Changes |
Health Authority: | United States: Federal Government |
stage I Wilms tumor stage II Wilms tumor stage III Wilms tumor |
stage IV Wilms tumor stage V Wilms tumor clear cell sarcoma of the kidney |
Anti-Infective Agents Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Etoposide phosphate Anti-Bacterial Agents Soft Tissue Sarcomas Renal Cancer Urologic Diseases Kidney Neoplasms Dactinomycin Wilms' Tumor Wilms Tumor |
Kidney Diseases Alkylating Agents Etoposide Kidney Cancer Sarcoma, Clear Cell Vincristine Antimitotic Agents Immunosuppressive Agents Doxorubicin Carcinoma Malignant Mesenchymal Tumor Tubulin Modulators Carcinoma, Renal Cell Sarcoma Antineoplastic Agents, Alkylating |
Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Antibiotics, Antineoplastic Anti-Bacterial Agents Neoplasms by Site Urologic Diseases Dactinomycin Kidney Neoplasms Therapeutic Uses |
Kidney Diseases Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Doxorubicin Pharmacologic Actions Carcinoma Protein Synthesis Inhibitors Neoplasms Tubulin Modulators |