Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

NCT ID: NCT01709253

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2015-12-31

Brief Summary

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Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Detailed Description

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Conditions

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Prostate Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

27pt/60CGE/20fx/5wks to PGTV(mon, tue, thu, fri; 4/wk)

Group Type EXPERIMENTAL

proton beam therapy

Intervention Type RADIATION

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Arm 2

27pt/54CGE/15fx/5wks to PGTV (mon, wed, fri; 3/wk)

Group Type EXPERIMENTAL

proton beam therapy

Intervention Type RADIATION

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Arm 3

27pt / 47CGE/10fx/5wk to PGTV(tue, thu;2/wk)

Group Type EXPERIMENTAL

proton beam therapy

Intervention Type RADIATION

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Arm 4

27pt/ 35CGE/ 5fx/2.5wk to PGTV(the, thu; 2/wk)

Group Type EXPERIMENTAL

proton beam therapy

Intervention Type RADIATION

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Interventions

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proton beam therapy

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Intervention Type RADIATION

Eligibility Criteria

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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)
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kwan Ho Cho

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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kwan ho cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

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National cancer center, korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Ha B, Cho KH, Lee KH, Joung JY, Kim YJ, Lee SU, Kim H, Suh YG, Moon SH, Lim YK, Jeong JH, Kim H, Park WS, Kim SH. Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation. Radiat Oncol. 2019 Jan 10;14(1):4. doi: 10.1186/s13014-019-1210-7.

Reference Type DERIVED
PMID: 30630500 (View on PubMed)

Other Identifiers

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NCCCTS 07-253

Identifier Type: -

Identifier Source: org_study_id

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