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Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01709253
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Kwan Ho Cho, National Cancer Center, Korea

Brief Summary:
Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Radiation: proton beam therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
Study Start Date : March 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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



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


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

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

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



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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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 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