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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 |
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 |
MedlinePlus related topics: | Cancer Testicular Cancer |
ChemIDplus related topics: | Carboplatin |
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.
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
Show 62 Study Locations |
Medical Research Council |
European Organization for Research and Treatment of Cancer |
Study Chair: | Hans Von Der Maase, MD | Aarhus Universitetshospital - Aarhus Sygehus |
Study Chair: | R. T. Oliver, MD | St. Bartholomew's Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Oliver RT, Mason MD, Mead GM, von der Maase H, Rustin GJ, Joffe JK, de Wit R, Aass N, Graham JD, Coleman R, Kirk SJ, Stenning SP; MRC TE19 collaborators and the EORTC 30982 collaborators. Radiotherapy versus single-dose carboplatin in adjuvant treatment of stage I seminoma: a randomised trial. Lancet. 2005 Jul 23-29;366(9482):293-300.
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Oliver RT, Mason M, Von der Masse H, et al.: A randomised comparison of single agent carboplatin with radiotherapy in the adjuvant treatment of stage I seminoma of the testis, following orchidectomy: MRC TE19/EORTC 30982. [Abstract] J Clin Oncol 22 (Suppl 14): A-4517, 386, 2004.
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Oliver RT, Mead GM, Fogarty PJ, et al.: Radiotherapy versus carboplatin for stage I seminoma: updated analysis of the MRC/EORTC randomized trial (ISRCTN27163214). [Abstract] J Clin Oncol 26 (Suppl 15): A-1, 2008.
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Study ID Numbers: | CDR0000065594, MRC-TE19, EORTC-30982, EU-97003 |
First Received: | November 1, 1999 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003014 |
Health Authority: | United States: Federal Government |
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