Radiation Therapy in Treating Patients With Relapsed Prostate Cancer After Surgery
NCT01272050 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2024-08-28
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.
Conditions
Interventions
- RADIATION
-
radiation therapy
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.
Sponsors & Collaborators
-
Swiss Cancer Institute
lead OTHER
Principal Investigators
-
Pirus Ghadjar, MD · Charite University, Berlin, Germany
-
Daniel M. Aebersold, Prof. · Bern University Hospital
-
George N. Thalmann, Prof. · Bern University Hospital
-
Daniel Zwahlen, PD Dr. · Kantonsspital Graubünden
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-06
- Primary Completion
- 2020-07-03
- Completion
- 2024-05-31
Countries
- Belgium
- Germany
- Switzerland
Study Locations
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