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| Sponsors and Collaborators: |
Medical Research Council European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003014 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Testicular Germ Cell Tumor |
Drug: carboplatin Procedure: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 |
| Estimated Enrollment: | 800 |
| Study Start Date: | April 1998 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed stage I seminomatous germ cell tumor of the testis categorized as either "classical" or "anaplastic"
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.4 mg/dL Other: No concurrent or previously treated malignancy except successfully treated nonmelanoma skin cancer No medical condition or other factor that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No more than 8 weeks since prior orchidectomy Prior inguino-pelvic or scrotal surgery allowed Must be treated with "dog-leg" field if randomized to radiotherapy If prior vasectomy, choice of fields is at the discretion of the clinician
Contacts and Locations
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 |
More Information
| Study ID Numbers: | CDR0000065594, MRC-TE19, EORTC-30982, EU-97003 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003014 |
| Health Authority: | United States: Federal Government |
|
stage I malignant testicular germ cell tumor testicular seminoma |
|
Neoplasms, Germ Cell and Embryonal Testicular Diseases Seminoma |
Testicular cancer Carboplatin Testicular Neoplasms |
|
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
