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Radiation Therapy in Treating Patients With Stage II Prostate Cancer

NCT00033631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1534

Last updated 2023-01-18

Study results available
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Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Conditions

Interventions

RADIATION

70.2 Gy 3D-CRT/IMRT

Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.

RADIATION

79.2 Gy 3D-CRT/IMRT

Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Jeff M. Michalski, MD · Washington University - Saint Louis

  • James Purdy, Ph.D. · UC Davis

  • Deborah W Bruner, Ph.D. · Emory University

  • Mahul Amin, M.D. · Cedars-Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2014-04-30
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 NCT00033631 on ClinicalTrials.gov