Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor

Phase 3

• Conditions: Kidney Cancer

• Registration Number: NCT00003804
• Lead Sponsor: University of Leicester

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1993-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-15
• Study First Posted: 2004-07-16
• Status Verified: 2012-04
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (44)

Clinique de l'Esperance; 🇧🇪 Montegnee, Belgium

Clinical Hospital Center Split; 🇭🇷 Split, Croatia

University Children Hospital; 🇨🇿 Brno, Czech Republic

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Universtiy Hospital of Aarhus; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Hopital Nord Amiens; 🇫🇷 Amiens, France

CHR de Besancon - Hopital Saint-Jacques; 🇫🇷 Besancon, France

CHU de Bordeaux - Hopital Pellegrin; 🇫🇷 Bordeaux, France

C.H.U. de Brest; 🇫🇷 Brest, France

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