Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
Not Applicable
Completed
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Radiation: proton beam therapy
- Registration Number
- NCT01709253
- Lead Sponsor
- National Cancer Center, Korea
- Brief Summary
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 117
Inclusion Criteria
Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry
Exclusion Criteria
Postoperative residual or recurrent tumor Evidence of distant metastases Previous irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 proton beam therapy 27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk) Arm 3 proton beam therapy 27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk) Arm 4 proton beam therapy 27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk) Arm 2 proton beam therapy 27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)
- Primary Outcome Measures
Name Time Method clinical outcomes up to 5years from a initial follow-up To evaluate biochemical failure-free survival (BCFFS)
- Secondary Outcome Measures
Name Time Method overall survival up to 5years from a initial follow-up to evaluated overall survival
acute toxicity up to 5years from a initial follow-up to evaluate acute toxicities by CTCAE version 3.0
late toxicity up to 5years from a initial follow-up to evaluated late toxicities by CTCAE version 3.0
Trial Locations
- Locations (1)
National cancer center, korea
🇰🇷Goyang-si, Gyeonggi-do,, Korea, Republic of