NCT00003014

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

Carboplatin in the Adjuvant Treatment of Stage I Seminoma: A Radomized Comparison of Single Agent Carboplatin With Radiotherapy in the Adjuvant Treatment of Stage I Seminoma of the Testis, Following Orchidectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	carboplatin
RADIATION	radiation therapy

Timeline

• Start date: 1998-04-01
• Completion: 2005-07-01
• First posted: 2004-03-12
• Last updated: 2013-12-04

Locations

62 sites across 7 countries: Brazil, Canada, Finland, Netherlands, Norway, South Africa, United Kingdom