Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor
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|ClinicalTrials.gov Identifier: NCT00003804|
Recruitment Status : Unknown
Verified April 2012 by National Cancer Institute (NCI) ( University of Leicester ).
Recruitment status was: Active, not recruiting
First Posted : July 16, 2004
Last Update Posted : June 24, 2014
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for stage I Wilms' tumor.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms' tumor.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Biological: dactinomycin Drug: vincristine sulfate Procedure: conventional surgery||Phase 3|
OBJECTIVES: I. Determine the initial extension of disease, surgical procedures, gross and histological morphology, treatments, clinical outcome, and late consequences of therapy after treatment with neoadjuvant chemotherapy, surgery, and adjuvant chemotherapy with or without maintenance chemotherapy in patients with intermediate risk or anaplastic stage I Wilms' tumor. II. Determine the safety and effectiveness of reduced chemotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients receive dactinomycin IV on days 1-3 and 15-17 and vincristine IV on days 1, 8, 15, and 22. Patients then undergo surgery about a week after completion of chemotherapy. After surgery, patients receive vincristine IV on days 1, 8, 15, and 22 and dactinomycin IV on days 8-12. Patients are then randomized to one of two treatment arms after week 9. Arm I: Patients receive dactinomycin IV on days 1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11. This course is repeated during weeks 17 and 18. Arm II: Patients receive no further treatment. Patients are followed every 3 months for 3 years, then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this study within 7-8 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Official Title:||Nephroblastoma Clinical Trial and Study|
|Study Start Date :||July 1993|
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|Ages Eligible for Study:||up to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
DISEASE CHARACTERISTICS: Initial diagnosis of a unilateral tumor with clinical and radiological characteristics of a nephroblastoma Histologically proven stage I Wilms' tumor after neoadjuvant treatment and surgery Intermediate risk or anaplastic No detectable distant metastases 4 weeks after adjuvant chemotherapy
PATIENT CHARACTERISTICS: Age: 0.5 to 17 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003804
|Study Chair:||Jan DeKraker, MD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Responsible Party:||University of Leicester|
|Other Study ID Numbers:||
|First Posted:||July 16, 2004 Key Record Dates|
|Last Update Posted:||June 24, 2014|
|Last Verified:||April 2012|
stage I Wilms tumor
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Complex and Mixed
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Nucleic Acid Synthesis Inhibitors