Testicular Germ Cell Tumor Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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