Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010244
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2001-02-02
Brief Title:
Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Conformational Curative Ratiotherapy For Prostate Cancer NO N- Phase III Multicenter Study Of The Contribution To Survival Without Clinical Or Biological Change With A Dose Variation Of 15 80 Gy VS 70 Gy
Status:
COMPLETED
Status Verified Date:
2021-02
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 which regimen of radiation therapy is more effective for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have localized prostate cancer
Detailed Description:
OBJECTIVES I Compare the 5-year survival rate in terms of clinical and biological remission in patients with localized prostate cancer treated with two different radiotherapy regimens using different doses and number of fractions II Compare the nadir of PSA and the delay in obtaining the nadir in patients treated with these two regimens III Compare acute and long-term toxicity of these two regimens in these patients IV Compare overall survival and quality of life in patients treated with these two regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms Arm I Patients receive radiotherapy to the seminal vesicles at 46 Gy in 23 fractions and to the prostate at 70 Gy in 35 fractions with 5 fractions per week Arm II Patients receive radiotherapy to the seminal vesicles as in arm I and to the prostate at 80 Gy in 40 fractions with 5 fractions per week Treatment continues in both arms in the absence of disease progression or unacceptable toxicity Quality of life is assessed annually Patients are followed every 4 months for a minimum of 5 years
PROJECTED ACCRUAL A total of 306 patients 153 per arm will be accrued for this study within 25 years
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms Arm I Patients receive radiotherapy to the seminal vesicles at 46 Gy in 23 fractions and to the prostate at 70 Gy in 35 fractions with 5 fractions per week Arm II Patients receive radiotherapy to the seminal vesicles as in arm I and to the prostate at 80 Gy in 40 fractions with 5 fractions per week Treatment continues in both arms in the absence of disease progression or unacceptable toxicity Quality of life is assessed annually Patients are followed every 4 months for a minimum of 5 years
PROJECTED ACCRUAL A total of 306 patients 153 per arm will be accrued for this study within 25 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20037 | REGISTRY | European Union | None |
| FRE-FNCLCC-PAC-GETUG-06-99001 | OTHER | None | None |