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

No results posted yet for this study

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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Entities

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 NCT01272050 on ClinicalTrials.gov