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Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwan Ho Cho, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01709253
First received: October 15, 2012
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Condition Intervention
Prostate Adenocarcinoma
Radiation: proton beam therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Further study details as provided by Kwan Ho Cho, National Cancer Center, Korea:

Primary Outcome Measures:
  • clinical outcomes [ Time Frame: up to 5years from a initial follow-up ]
    To evaluate biochemical failure-free survival (BCFFS)


Secondary Outcome Measures:
  • acute toxicity [ Time Frame: up to 5years from a initial follow-up ]
    to evaluate acute toxicities by CTCAE version 3.0

  • late toxicity [ Time Frame: up to 5years from a initial follow-up ]
    to evaluated late toxicities by CTCAE version 3.0

  • overall survival [ Time Frame: up to 5years from a initial follow-up ]
    to evaluated overall survival


Enrollment: 117
Study Start Date: March 2007
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709253

Locations
Korea, Republic of
National cancer center, korea
Goyang-si, Gyeonggi-do,, Korea, Republic of, 411-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: kwan ho cho, M.D. National Cancer Center, Korea
  More Information

Responsible Party: Kwan Ho Cho, M.D., National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01709253     History of Changes
Other Study ID Numbers: NCCCTS 07-253
Study First Received: October 15, 2012
Last Updated: March 27, 2017

Keywords provided by Kwan Ho Cho, National Cancer Center, Korea:
hpofractionation study using proton beam therapy

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 25, 2017