A Phase 3 interventional study of carboplatin and radiation therapy in Testicular Germ Cell Tumor, sponsored by Medical Research Council. Completed at 62 sites in 7 countries. Open to male participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-12-04.
Sponsored by Medical Research Council · Phase 3, Interventional, and Treatment
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.
85 studies on the registry are indexed under Testicular Germ Cell Tumor; 10 are open to participants now.
This study's planned enrollment of 800 is above the median of 46 across 54 interventional studies indexed under Testicular Germ Cell Tumor.
Browse Testicular Germ Cell Tumor studies →Medical Research Council is the lead sponsor of 68 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS: 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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Apr 1998 and a completion of Jul 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carboplatin
Medical Research Council