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Clinical Trials/NCT01709253
NCT01709253
Completed
Not Applicable

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

National Cancer Center, Korea1 site in 1 country117 target enrollmentMarch 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Adenocarcinoma
Sponsor
National Cancer Center, Korea
Enrollment
117
Locations
1
Primary Endpoint
clinical outcomes
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kwan Ho Cho

M.D.

National Cancer Center, Korea

Eligibility Criteria

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)

Outcomes

Primary Outcomes

clinical outcomes

Time Frame: up to 5years from a initial follow-up

To evaluate biochemical failure-free survival (BCFFS)

Secondary Outcomes

  • acute toxicity(up to 5years from a initial follow-up)
  • late toxicity(up to 5years from a initial follow-up)
  • overall survival(up to 5years from a initial follow-up)

Study Sites (1)

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