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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: | NCT00379340 |
RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin hydrochloride Drug: etoposide Drug: vincristine sulfate Procedure: conventional surgery Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors |
Estimated Enrollment: | 295 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 29 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed Wilms' tumor meeting 1 of the following criteria:
Stage IV disease with favorable histology with or without loss of heterozygosity (LOH) for 1p and 16q
Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | David B. Dix, MD, FRCP, MBChB | Children's & Women's Hospital of British Columbia |
Study ID Numbers: | CDR0000496508, COG-AREN0533 |
Study First Received: | September 19, 2006 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00379340 |
Health Authority: | Unspecified |
stage III Wilms tumor stage IV Wilms tumor |
Wilms' tumor Vincristine Urogenital Neoplasms Cyclophosphamide Renal cancer Urologic Neoplasms Kidney cancer Etoposide phosphate Doxorubicin Carcinoma Neoplastic Syndromes, Hereditary |
Urologic Diseases Genetic Diseases, Inborn Dactinomycin Kidney Neoplasms Carcinoma, Renal Cell Wilms Tumor Kidney Diseases Adenocarcinoma Etoposide Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Anti-Bacterial Agents Neoplasms by Site Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators |
Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Neoplasms, Complex and Mixed |