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ACTIVE NOT RECRUITING
NCT03438552
NA

Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence

Sponsor: UNICANCER

View on ClinicalTrials.gov

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

RADIATION

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