Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021450
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2001-07-13
Brief Title:
Radiation Therapy With or Without Bicalutamide and Goserelin 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:
Three Dimensional Conformal Radiotherapy Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c T2a N0 M0 Prostatic Carcinoma A Phase III Randomized Study
Status:
COMPLETED
Status Verified Date:
2016-09
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 Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer
Detailed Description:
OBJECTIVES
Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer
Compare the acute and late radiation-induced side effects of these regimens in these patients
Compare the biochemicalclinical disease-free survival overall survival and time to local progression in patients treated with these regimens
Compare the time to clinical biological failure or death in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor class T1b-c vs T2a initial prostate-specific antigen level 10 ngmL vs 10-20 ngmL vs greater than 20 ngmL Gleason score 2-6 vs 7-10 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-75 weeks
Arm II Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98 Beginning on day 8 patients undergo radiotherapy as in arm I
Quality of life is assessed at baseline and then at months 6 12 24 and 36
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients 400 per treatment arm will be accrued for this study within 5 years
Compare the potential beneficial impact of radiotherapy with or without adjuvant bicalutamide and goserelin on the long-term outcome of patients with localized prostate cancer
Compare the acute and late radiation-induced side effects of these regimens in these patients
Compare the biochemicalclinical disease-free survival overall survival and time to local progression in patients treated with these regimens
Compare the time to clinical biological failure or death in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor class T1b-c vs T2a initial prostate-specific antigen level 10 ngmL vs 10-20 ngmL vs greater than 20 ngmL Gleason score 2-6 vs 7-10 and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for 7-75 weeks
Arm II Patients receive adjuvant oral bicalutamide once daily on days 1-30 and goserelin subcutaneously on days 8 and 98 Beginning on day 8 patients undergo radiotherapy as in arm I
Quality of life is assessed at baseline and then at months 6 12 24 and 36
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients 400 per treatment arm will be accrued for this study within 5 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-22991 | None | None | None |