Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003014
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Radiation Therapy Compared With Chemotherapy in Treating Patients With Stage I Testicular Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-97003 | None | None | None |
| MRC-TE19 | None | None | None |
| EORTC-30982 | None | None | None |