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Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma


Phase 2
N/A
N/A
Open (Enrolling)
Male
Prostate Adenocarcinoma

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Trial Information

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

clinical outcomes

Outcome Description:

To evaluate biochemical failure-free survival (BCFFS)

Outcome Time Frame:

up to 5years from a initial follow-up

Safety Issue:

Yes

Principal Investigator

kwan ho cho, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

NCCCTS 07-253

NCT ID:

NCT01709253

Start Date:

March 2007

Completion Date:

December 2012

Related Keywords:

  • Prostate Adenocarcinoma
  • hpofractionation study using proton beam therapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

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