CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,116 enrolled
Drug / intervention
Conventional 3D-CRT or IMRT +1 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00331773
NCT00331773Phase 3Completed
CompareCT.gov

A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer

Radiation Therapy Oncology Group·interventional·Posted May 31, 2006·Updated Jan 18, 2023

In Brief

A Phase 3 clinical trial evaluating Conventional 3D-CRT or IMRT and Hypofractionated 3D-CRT or IMRT for Prostate Cancer. Completed, enrolled 1,116 participants across 296 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI), NRG Oncology

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 31, 2006
Enrollment StartApr 1, 2006
Primary CompletionJul 1, 2015
Study CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.1 years ago

Interventions

Conventional 3D-CRT or IMRTradiation

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

Hypofractionated 3D-CRT or IMRTradiation

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.