Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002602
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
1999-11-01
Brief Title:
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A PHASE III DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY FOR ADENOCARCINOMA OF THE PROSTATE
Status:
COMPLETED
Status Verified Date:
2015-03
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 to damage tumor cells and may be an effective treatment for prostate cancer
PURPOSE Phase III trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer
PURPOSE Phase III trial to study the effectiveness of radiation therapy in treating patients who have previously untreated stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy to the prostate gland and immediately surrounding tissues in patients with stage II or III adenocarcinoma of the prostate II Determine the normal tissue toxicity rate of this regimen in the rectums and bladders of these patients III Determine local control by clinical and pathologic examination and by PSA determinations in patients treated with this regimen IV Determine the distant failure and overall survival of patients treated with this regimen
OUTLINE This is a dose escalation study Patients are stratified according to 1 of the following 3 prognostic groups Group 1 T1b-c or T2a-b with combined PSAGleason CPG score 15 and under Group 2 T1b-c or T2a-b with CPG score more than 15 or any T2c with PSA less than 70 ngmL Group 3 T3 with prostate specific antigen PSA less than 70 ngmL Patients receive 3-dimensional 3-D conformal radiotherapy 5 days a week for 76 82 or 88 weeks Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 20 of patients experience dose-limiting toxicity Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 549-801 patients 120-204 patients for the first dose level 237-321 patients for the second dose level and 192-276 patients for the third dose level will be accrued for this study within 475 to 525 years
OUTLINE This is a dose escalation study Patients are stratified according to 1 of the following 3 prognostic groups Group 1 T1b-c or T2a-b with combined PSAGleason CPG score 15 and under Group 2 T1b-c or T2a-b with CPG score more than 15 or any T2c with PSA less than 70 ngmL Group 3 T3 with prostate specific antigen PSA less than 70 ngmL Patients receive 3-dimensional 3-D conformal radiotherapy 5 days a week for 76 82 or 88 weeks Cohorts of 120-270 patients receive escalating doses of 3-D conformal radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 20 of patients experience dose-limiting toxicity Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 549-801 patients 120-204 patients for the first dose level 237-321 patients for the second dose level and 192-276 patients for the third dose level will be accrued for this study within 475 to 525 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 |
|---|---|---|---|
| CDR0000063854 | None | None | None |