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Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence
Sponsor: UNICANCER
Summary
Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy. The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment. The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.
Official title: Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2018-10-18
Completion Date
2030-11
Last Updated
2024-12-20
Healthy Volunteers
No
Interventions
Stereotactic Body Radiotherapy
This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.
Locations (12)
Centre François Baclesse
Caen, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre George François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Institut régional du Cancer de Montpellier
Montpellier, France
Groupe Hospitalier Pitié-Salpétrière
Paris, France
DE CREVOISIER Renaud
Rennes, France
ICO -Site René Gauducheau
Saint-Herblain, France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
CHRU Henry S.Kaplan
Tours, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France