Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258466
Status:
WITHDRAWN
Last Update Posted:
2013-04-08
First Post:
2005-11-23
Brief Title:
Radiation Therapy in Treating Patients With Stage I Stage II or Stage III Prostate Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase III Trial of Neutron Photon Radiation Versus Photon Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-04
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 types of radiation to kill tumor cells Giving radiation therapy in different ways may kill more tumor cells It is not yet known which type of radiation therapy is more effective in treating prostate cancer
PURPOSE This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I stage II or stage III prostate cancer
PURPOSE This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation in terms of a lower frequency of chronic complication rate chronic toxicity and disease-free survival in patients with favorable to intermediate prognosis stage I-III adenocarcinoma of the prostate
OUTLINE This is a randomized multicenter study Patients are stratified according to stage of disease T1 vs T2 vs T3 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks
Arm II Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks
After completion of study treatment patients are followed periodically for 5 years and then yearly thereafter
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for this study
Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation in terms of a lower frequency of chronic complication rate chronic toxicity and disease-free survival in patients with favorable to intermediate prognosis stage I-III adenocarcinoma of the prostate
OUTLINE This is a randomized multicenter study Patients are stratified according to stage of disease T1 vs T2 vs T3 Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks
Arm II Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks
After completion of study treatment patients are followed periodically for 5 years and then yearly thereafter
PROJECTED ACCRUAL A total of 300 patients 150 per treatment arm will be accrued for 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 |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-2879 | None | None | None |
| WSU-HIC-047405MP4F | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |