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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00379340
  Purpose

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
Kidney Cancer
Drug: cyclophosphamide
Drug: dactinomycin
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Procedure: radiation therapy
Phase III

MedlinePlus related topics: Cancer Kidney Cancer Wilms' Tumor
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Etoposide Vincristine sulfate Vincristine Etoposide phosphate Dactinomycin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival as measured by Woolson and an O'Brien-Fleming Boundary at 4 years [ Designated as safety issue: No ]

Estimated Enrollment: 295
Study Start Date: February 2007
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

      • Has undergone nephrectomy within the past 2 weeks
    • Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532

      • Enrolled in this study before beginning week 7 chemotherapy
  • Previously enrolled in clinical trial COG-AREN03B2

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky PS 50-100% (for patients ≤ 16 years of age)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST or ALT < 2.5 times ULN
  • Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior tumor-directed chemotherapy or radiotherapy unless transferring from clinical trial COG-AREN0532
  • No concurrent aprepitant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379340

  Show 150 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: David B. Dix, MD, FRCP, MBChB Children's & Women's Hospital of British Columbia
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000496508, COG-AREN0533
Study First Received: September 19, 2006
Last Updated: November 21, 2008
ClinicalTrials.gov Identifier: NCT00379340  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III Wilms tumor
stage IV Wilms tumor

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009