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Radiation Therapy in Treating Patients With Stage II Prostate Cancer

NCT00331773 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1116

Last updated 2023-01-18

Study results available
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Summary

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.

Conditions

Interventions

RADIATION

Conventional 3D-CRT or IMRT

Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy

RADIATION

Hypofractionated 3D-CRT or IMRT

Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • W. Robert Lee, MD, MS · Duke Cancer Institute

  • Mahul B Amin, MD · Cedars-Sinai Medical Center

  • Deborah W Bruner, RN, PhD · University of Pennsylvania

  • Daniel Low, PhD · Washington University School of Medicine

  • Gregory P Swanson, MD · UTHSC San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2015-07-31
Completion
2022-12-22

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00331773 on ClinicalTrials.gov