Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331773
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2006-05-30
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 Hypofractionated 3D-CRTMRT Versus Conventionally Fractionated 3D-CRTMRT in Patients With Favorable-Risk 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 Giving radiation therapy that uses a 3-dimensional 3-D image of the tumor to help focus thin beams of radiation directly on the tumor and giving hypofractionated radiation therapy higher doses over a shorter period of time may be less costly with fewer side effects and just as effective in treating prostate cancer
PURPOSE This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer
PURPOSE This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare the disease-free survival DFS of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy 3D-CRT or intensity-modulated radiotherapy IMRT
Secondary
Compare time to local progression freedom from biochemical recurrence and disease-specific and overall survival of patients treated with these regimens
Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens
Compare the degree duration and significant differences in disease-specific health-related quality of life HRQOL decrements using the Expanded Prostate Cancer Index Composite EPIC in patients treated with these regimens
Determine whether anxiety andor depression as measured by the Hopkins Symptom Checklist-25 HSCL-25 are decreased with therapy that improves DFS of these patients
Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL ie mobility self care usual activities paindiscomfort and anxietydepression in patients treated with these regimens
Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to Gleason score 2-4 vs 5-6 prostate-specific antigen PSA level 4 ngmL vs 4-9 ngmL and planned radiotherapy 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 82 weeks total of 41 treatments
Arm II Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 56 weeks total of 28 treatments
Quality of life anxiety and depression are assessed at baseline and then at 6 months and 1 2 and 5 years after the start of radiotherapy
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1067 patients will be accrued to this study
Primary
Compare the disease-free survival DFS of patients with favorable-risk stage II prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy 3D-CRT or intensity-modulated radiotherapy IMRT
Secondary
Compare time to local progression freedom from biochemical recurrence and disease-specific and overall survival of patients treated with these regimens
Determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens
Compare the degree duration and significant differences in disease-specific health-related quality of life HRQOL decrements using the Expanded Prostate Cancer Index Composite EPIC in patients treated with these regimens
Determine whether anxiety andor depression as measured by the Hopkins Symptom Checklist-25 HSCL-25 are decreased with therapy that improves DFS of these patients
Determine whether the incremental gain in DFS outweighs decrements in the generic domains of HRQOL ie mobility self care usual activities paindiscomfort and anxietydepression in patients treated with these regimens
Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3D-CRT or IMRT in improving DFS
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to Gleason score 2-4 vs 5-6 prostate-specific antigen PSA level 4 ngmL vs 4-9 ngmL and planned radiotherapy 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a week for 82 weeks total of 41 treatments
Arm II Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for 56 weeks total of 28 treatments
Quality of life anxiety and depression are assessed at baseline and then at 6 months and 1 2 and 5 years after the start of radiotherapy
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 1067 patients will be accrued to 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 |
|---|---|---|---|
| CDR0000481119 | None | None | None |
| NCI-2009-00721 | REGISTRY | CTRP Clinical Trial Reporting Program | None |