CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 350 enrolled
Drug / intervention
radiation therapyradiation
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/NCT01272050
NCT01272050Phase 3Completed

Dose Intensified Salvage Radiotherapy in Biochemically Relapsed Prostate Cancer Without Macroscopic Disease. A Randomized Phase III Trial.

Swiss Cancer Institute·interventional·Posted Jan 7, 2011·Updated Aug 28, 2024

In Brief

A Phase 3 clinical trial evaluating radiation therapy for Prostate Cancer. Completed, enrolled 350 participants across 28 sites in 3 countries.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with relapsed prostate cancer. PURPOSE: This randomized phase III trial is studying the side effects of radiation therapy and comparing two radiation therapy regimens in treating patients with relapsed prostate cancer after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, Germany, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartJan 6, 2011
Primary CompletionJul 3, 2020
Study CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 15.5 years ago

Interventions

radiation therapyradiation

RT in the standard arm A will be administered to a total dose of 64 Gy in 32 fractions of 2 Gy over 6.4 weeks. RT in the experimental arm B will be administered to a total dose of 70 Gy in 35 fractions of 2 Gy over 7 weeks. Megavoltage equipments with nominal photon energies ≥ 6 MV are required. Rotational techniques such as Tomotherapy®, Rapidarc®, intensity-modulated arc technique (IMAT) and volumetric-modulated arc therapy (VMAT) will also be eligible. The patient will be treated in an isocentric setting and all fields will be applied for 5 days per week for the total RT duration.