Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003607
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Stage I Stage II or Stage III Prostate Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I II or III Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2016-06
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 It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I stage II or stage III prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Compare the survival without recurrence and overall survival of patients with stage I II or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis
Compare the toxic effects of these two regimens in these patients
Compare the quality of life of patients treated with these regimens
Determine the prognostic factors of progression in these patients
Analyze the site of relapse prostate pelvic lymph nodes metastases in case of progression in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by participating center and prognostic group poor vs good prognosis
Patients are randomized to one of two treatment arms
Arm I Patients receive pelvic irradiation plus local prostate irradiation
Arm II Patients receive local prostate irradiation only Radiotherapy in both arms is administered 5 days a week for 7 weeks
Quality of life is assessed before therapy 12 months after therapy and then annually thereafter
Patients are followed at 2 and 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 4 years
Compare the survival without recurrence and overall survival of patients with stage I II or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis
Compare the toxic effects of these two regimens in these patients
Compare the quality of life of patients treated with these regimens
Determine the prognostic factors of progression in these patients
Analyze the site of relapse prostate pelvic lymph nodes metastases in case of progression in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by participating center and prognostic group poor vs good prognosis
Patients are randomized to one of two treatment arms
Arm I Patients receive pelvic irradiation plus local prostate irradiation
Arm II Patients receive local prostate irradiation only Radiotherapy in both arms is administered 5 days a week for 7 weeks
Quality of life is assessed before therapy 12 months after therapy and then annually thereafter
Patients are followed at 2 and 6 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 450 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98029 | None | None | None |
| FRE-FNCLCC-GETUG-01 | None | None | None |