Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
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| ClinicalTrials.gov Identifier: NCT00003014 |
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Recruitment Status :
Completed
First Posted : March 12, 2004
Last Update Posted : December 4, 2013
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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 |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Completion Date : | July 2005 |
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003014
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| Study Chair: | Hans Von Der Maase, MD | Aarhus Universitetshospital - Aarhus Sygehus | |
| Study Chair: | R. T. Oliver, MD | St. Bartholomew's Hospital |
Other Publications:
| ClinicalTrials.gov Identifier: | NCT00003014 |
| Other Study ID Numbers: |
CDR0000065594 MRC-TE19 EORTC-30982 EU-97003 |
| First Posted: | March 12, 2004 Key Record Dates |
| Last Update Posted: | December 4, 2013 |
| Last Verified: | March 2011 |
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stage I malignant testicular germ cell tumor testicular seminoma |
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Neoplasms, Germ Cell and Embryonal Seminoma Neoplasms by Histologic Type Neoplasms |
Germinoma Carboplatin Antineoplastic Agents |