Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062309
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2003-06-05
Brief Title:
Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
Status:
COMPLETED
Status Verified Date:
2016-03
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 Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells It is not yet known which radiation therapy regimen is more effective in treating prostate cancer
PURPOSE This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer
PURPOSE This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of conventional intensity-modulated radiotherapy IMRT vs hypofractionated IMRT in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer
Compare the local control freedom from distant metastasis and overall survival of patients treated with these regimens
Determine local failure using biopsy of the prostate when objective tests prostate-specific antigen ultrasound and digital rectal exam suggest relapse in these patients
Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients
Compare the quality of life of patients treated with these regimens
Determine the impact of these regimens on patient preferences and utilities
OUTLINE This is a randomized study Patients are stratified according to pretreatment prostate-specific antigen no greater than 10 ngmL vs greater than 10 to 20 ngmL vs greater than 20 ngmL Gleason score 5-7 vs 8-10 and risk status high risk vs intermediate risk Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conventional intensity-modulated radiotherapy IMRT 5 days a week for 75 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity
Patients with high-risk disease also undergo androgen deprivation therapy for 2 years
Quality of life is assessed at baseline every 6 months for 1 year and then annually for 4 years
Patients are followed at 3 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study within 3 years
Compare the efficacy of conventional intensity-modulated radiotherapy IMRT vs hypofractionated IMRT in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer
Compare the local control freedom from distant metastasis and overall survival of patients treated with these regimens
Determine local failure using biopsy of the prostate when objective tests prostate-specific antigen ultrasound and digital rectal exam suggest relapse in these patients
Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients
Compare the quality of life of patients treated with these regimens
Determine the impact of these regimens on patient preferences and utilities
OUTLINE This is a randomized study Patients are stratified according to pretreatment prostate-specific antigen no greater than 10 ngmL vs greater than 10 to 20 ngmL vs greater than 20 ngmL Gleason score 5-7 vs 8-10 and risk status high risk vs intermediate risk Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo conventional intensity-modulated radiotherapy IMRT 5 days a week for 75 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity
Patients with high-risk disease also undergo androgen deprivation therapy for 2 years
Quality of life is assessed at baseline every 6 months for 1 year and then annually for 4 years
Patients are followed at 3 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| FCCC-02602 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |