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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 1, 1999 | ||||||||
| Last Updated Date | February 6, 2009 | ||||||||
| Start Date ICMJE | April 1998 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00003014 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. |
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| 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. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized | ||||||||
| Condition ICMJE | Testicular Germ Cell Tumor | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | 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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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 800 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Male | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil, Canada, Finland, Netherlands, Norway, South Africa, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00003014 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000065594, MRC-TE19, EORTC-30982, EU-97003 | ||||||||
| Study Sponsor ICMJE | Medical Research Council | ||||||||
| Collaborators ICMJE | European Organization for Research and Treatment of Cancer | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | June 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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