CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 255 enrolled
Drug / intervention
36.25 Gy 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/NCT01434290
NCT01434290Phase 2Completed

A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer

Radiation Therapy Oncology Group·interventional·Posted Sep 14, 2011·Updated Jun 9, 2022

In Brief

A Phase 2 clinical trial evaluating 36.25 Gy IMRT and 51.6 Gy IMRT for Prostate Cancer and 3 related conditions. Completed, enrolled 255 participants across 37 sites in 2 countries.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2011
Enrollment StartSep 1, 2011
Primary CompletionJun 1, 2015
Study CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.8 years ago

Interventions

36.25 Gy IMRTradiation

36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.

51.6 Gy IMRTradiation

51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.