Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033631
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2002-04-09
Brief Title:
Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Randomized Study Of High Dose 3D-CRTIMRT Versus Standard Dose 3D-CRTIMRT In Patients Treated For Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2022-12
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 Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy
Compare the freedom from prostate-specific antigen failure disease-specific survival local progression and distant metastases in patients treated with these regimens
Compare the probability of tumor control and normal tissue complications in patients treated with these regimens
Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens
Compare the quality of life including sexual function of patients treated with these regimens
Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Gleason score and prostate-specific antigen PSA level Gleason score 2-6 PSA 10 mgmL but 20 ngmL vs Gleason score 7 PSA 15 ngmL and radiation modality three-dimensional conformal radiotherapy 3D-CRT vs intensity-modulated radiotherapy IMRT Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo standard-dose 3D-CRT or IMRT once daily 5 days a week for 78 weeks 39 treatment days
Arm II Patients undergo high-dose 3D-CRT or IMRT once daily 5 days a week for 88 weeks 44 treatment days
Quality of life QOL is assessed initially at baseline After completion of radiotherapy QOL is assessed every 3 months for 1 year and then every 6 months for 4 years
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1520 patients 760 per treatment arm will be accrued for this study within 5 years
Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy
Compare the freedom from prostate-specific antigen failure disease-specific survival local progression and distant metastases in patients treated with these regimens
Compare the probability of tumor control and normal tissue complications in patients treated with these regimens
Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens
Compare the quality of life including sexual function of patients treated with these regimens
Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Gleason score and prostate-specific antigen PSA level Gleason score 2-6 PSA 10 mgmL but 20 ngmL vs Gleason score 7 PSA 15 ngmL and radiation modality three-dimensional conformal radiotherapy 3D-CRT vs intensity-modulated radiotherapy IMRT Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo standard-dose 3D-CRT or IMRT once daily 5 days a week for 78 weeks 39 treatment days
Arm II Patients undergo high-dose 3D-CRT or IMRT once daily 5 days a week for 88 weeks 44 treatment days
Quality of life QOL is assessed initially at baseline After completion of radiotherapy QOL is assessed every 3 months for 1 year and then every 6 months for 4 years
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1520 patients 760 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 |
|---|---|---|---|
| CDR0000069306 | None | None | None |