Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
|ClinicalTrials.gov Identifier: NCT00003014|
Recruitment Status : Completed
First Posted : March 12, 2004
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Testicular Germ Cell Tumor||Drug: carboplatin Radiation: radiation therapy||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Official Title:||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|
|Study Start Date :||April 1998|
|Study Completion Date :||July 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003014
Show 62 Study Locations
|Study Chair:||Hans Von Der Maase, MD||Aarhus Universitetshospital - Aarhus Sygehus|
|Study Chair:||R. T. Oliver, MD||St. Bartholomew's Hospital|