Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423475
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2007-01-16
Brief Title:
Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-05
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 kill tumor cells Androgens can cause the growth of prostate cancer cells Antihormone therapy such as goserelin may stop the adrenal glands from making androgens Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer
PURPOSE This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer
PURPOSE This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin in terms of biological andor clinical progression-free survival in patients who have undergone surgery for recurrent or refractory prostate cancer
Secondary
Compare overall survival of patients treated with these regimens
Compare metastases-free survival of patients treated with these regimens
Compare the immediate and delayed toxicities of these regimens
Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens
Compare the quality of life at 1 and 5 years after radiotherapy in these patients
Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over
OUTLINE This is an open-label randomized parallel-group multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for 7 weeks
Arm II Patients undergo radiotherapy as in arm I Patients also receive goserelin subcutaneously on day 1 and again 3 months later
Quality of life is assessed periodically
After completion of study therapy patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 466 patients will be accrued for this study
Primary
Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin in terms of biological andor clinical progression-free survival in patients who have undergone surgery for recurrent or refractory prostate cancer
Secondary
Compare overall survival of patients treated with these regimens
Compare metastases-free survival of patients treated with these regimens
Compare the immediate and delayed toxicities of these regimens
Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens
Compare the quality of life at 1 and 5 years after radiotherapy in these patients
Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over
OUTLINE This is an open-label randomized parallel-group multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy once daily 5 days a week for 7 weeks
Arm II Patients undergo radiotherapy as in arm I Patients also receive goserelin subcutaneously on day 1 and again 3 months later
Quality of life is assessed periodically
After completion of study therapy patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 466 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000523446 | None | None | None |
| EUDRACT-2005-005165-11 | None | None | None |