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 November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00379340
First received: September 19, 2006
Last updated: November 3, 2012
Last verified: November 2012
  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
Metastatic Cancer
Biological: dactinomycin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Resource links provided by NLM:


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: 400
Study Start Date: February 2007
Estimated Primary Completion Date: July 2016 (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
    • Stage III disease with favorable histology with LOH for 1p and 16q transferring from clinical trial COG-AREN0532
  • Patients must begin therapy within 14 days after surgery or biopsy (day 0), unless medically contraindicated
  • Extra-pulmonary metastases include lymph node involvement in the hilum and/or mediastinum deemed by the treating institution to represent malignant disease, or positive cytology-proven pleural effusions
  • No bilateral Wilms tumors (stage IV)

    • Patients should be referred to COG-AREN0534
  • 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 OR treatment for emergent issues, as medically indicated
  • No concurrent aprepitant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379340

  Show 201 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: David B. Dix, MD, FRCP, MBChB Children's and Women's Hospital of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT00379340     History of Changes
Other Study ID Numbers: CDR0000496508, COG-AREN0533
Study First Received: September 19, 2006
Last Updated: November 3, 2012
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Wilms Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Dactinomycin
Doxorubicin
Cyclophosphamide
Etoposide
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013