Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer

Phase 3

Completed

• Conditions: Testicular Germ Cell Tumor

• Registration Number: NCT00003014
• Lead Sponsor: Medical Research Council

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective than radiation therapy for testicular cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with that of radiation therapy in treating patients who have stage I testicular cancer.

Detailed Description

OBJECTIVES: I. Compare relapse rates in patients with stage I testicular seminoma treated with adjuvant radiotherapy vs carboplatin. II. Compare quality of life of patients before and after treatment with these regimens. III. Compare the acute and intermediate (1-2 year) side effects of these regimens in these patients. IV. Determine the incidence of late side effects (such as bowel dysfunction) of treatment and second malignancies in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive a single dose of carboplatin IV. Arm II: Patients undergo radiotherapy once daily, 5 days a week. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 800 patients will be accrued for this study within 4 years.

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-03-11
• Study First Posted: 2004-03-12
• Study Completion: 2005-07
• Status Verified: 2011-03
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (62)

Porto Alegre Hospital; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Cancer Care Ontario-London Regional Cancer Centre; 🇨🇦 London, Ontario, Canada

Mount Sinai Hospital - Toronto; 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Hopital Sainte Justine; 🇨🇦 Montreal, Quebec, Canada

Maria Hospital; 🇫🇮 Helsinki, Finland

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Groote Schuur Hospital, Cape Town; 🇿🇦 Cape Town, South Africa

Royal United Hospital; 🇬🇧 Bath, England, United Kingdom

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