Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

March 27, 2017 updated by: Kwan Ho Cho, National Cancer Center, Korea
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do,
      • Goyang-si, Gyeonggi-do,, Korea, Republic of, 411-769
        • National Cancer Center, Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk)
Radiation: proton beam therapy
hypofractionation study using proton beam therapy for prostate adenocarcinoma
Experimental: Arm 2
27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)
Radiation: proton beam therapy
hypofractionation study using proton beam therapy for prostate adenocarcinoma
Experimental: Arm 3
27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk)
Radiation: proton beam therapy
hypofractionation study using proton beam therapy for prostate adenocarcinoma
Experimental: Arm 4
27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk)
Radiation: proton beam therapy
hypofractionation study using proton beam therapy for prostate adenocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcomes
Time Frame: up to 5years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
up to 5years from a initial follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute toxicity
Time Frame: up to 5years from a initial follow-up
to evaluate acute toxicities by CTCAE version 3.0
up to 5years from a initial follow-up
late toxicity
Time Frame: up to 5years from a initial follow-up
to evaluated late toxicities by CTCAE version 3.0
up to 5years from a initial follow-up
overall survival
Time Frame: up to 5years from a initial follow-up
to evaluated overall survival
up to 5years from a initial follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Kwan Ho Cho, M.D., National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS 07-253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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