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OpenTrials
Completed

NCT Number: NCT01709253

Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

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Key information

Conditions

Prostate Adenocarcinoma

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National cancer center, korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Proton beam therapy

Radiation

hypofractionation study using proton beam therapy for prostate adenocarcinoma

Primary outcomes

  1. clinical outcomes

    Time frame: up to 5years from a initial follow-up

    To evaluate biochemical failure-free survival (BCFFS)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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