Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002511
Status:
COMPLETED
Last Update Posted:
2012-10-16
First Post:
1999-11-01
Brief Title:
Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
Status:
COMPLETED
Status Verified Date:
2012-10
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 Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer
PURPOSE Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy
PURPOSE Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy
Detailed Description:
OBJECTIVES
Compare local recurrence rates acute and late morbidity overall survival disease-free survival and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation 60 Gy vs no further treatment until relapse
Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease
OUTLINE This is a randomized study
Arm I Patients undergo radiotherapy daily 5 days a week for 5 weeks followed by boost radiotherapy for 1-14 weeks
Arm II Patients are observed Local relapse is treated with conventional pelvic radiotherapy
Patients are followed every 3 months during the first postoperative year every 6 months until the fifth year and annually thereafter
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study within 75 years
Compare local recurrence rates acute and late morbidity overall survival disease-free survival and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation 60 Gy vs no further treatment until relapse
Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease
OUTLINE This is a randomized study
Arm I Patients undergo radiotherapy daily 5 days a week for 5 weeks followed by boost radiotherapy for 1-14 weeks
Arm II Patients are observed Local relapse is treated with conventional pelvic radiotherapy
Patients are followed every 3 months during the first postoperative year every 6 months until the fifth year and annually thereafter
PROJECTED ACCRUAL A total of 1000 patients will be accrued for this study within 75 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 |
|---|---|---|---|
| EORTC-GU-22911 | None | None | None |
| EORTC-22911 | None | None | None |