Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Cancer Center, Korea.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kwan Ho Cho, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01709253
First received: October 15, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma


Condition Intervention Phase
Prostate Adenocarcinoma
Radiation: proton beam therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

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

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


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

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

  • overall survival [ Time Frame: up to 5years from a initial follow-up ] [ Designated as safety issue: No ]
    to evaluated overall survival


Estimated Enrollment: 117
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Genders 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

Contacts
Contact: kwan ho cho, M.D. +82 31 920 1720 kwancho@ncc.re.kr

Locations
Korea, Republic of
National cancer center, korea Recruiting
Goyang-si, Gyeonggi-do,, Korea, Republic of, 411-769
Contact: kwan ho cho, M.D.    +82 31 920 1720    kwancho@ncc.re.kr   
Sub-Investigator: kang hyun lee, M.D.         
Sub-Investigator: Byong ho nam, ph.D.         
Sub-Investigator: yeon-joo kim, M.D.         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: kwan ho cho, M.D. National Cancer Center, Korea
  More Information

No publications provided

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: October 16, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014