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Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
Sponsor: Hospices Civils de Lyon
Summary
This is a transnational prospective randomized trial comparing definitive carbon ion therapy versus photon or combined photon and protontherapy as standard treatment for unresectable or macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously irradiated and without pre-planned surgery or chemotherapy after the clinical trial procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated in carbon ions centers in Europe and patients of the standard arm are treated in France in their closest participating radiotherapy center. An accrual of 250 patients is needed and an absolute difference of 20% of relapse free survival at five years is awaited. The main endpoint is the progression free survival at five years. The trial is supported by the French program of clinical research and the national health insurance. Two associated studies are carried out: a radiobiological one looking for radioresistance markers in the sarcomas biopsies, and the second one is about medico economics.
Official title: Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2017-12-23
Completion Date
2026-12-23
Last Updated
2021-09-02
Healthy Volunteers
No
Interventions
Carbon ions therapy
External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
Advanced external radiotherapy by Xrays or protons
Radiotherapy by any appropriate advance procedure of photontherapy (IMRT, Volumetric Modulated Arc Therapy (VMAT), Tomo, etc.) or when possible by protontherapy or even a combination of both types of radiotherapy
Locations (21)
CHU Amiens - Hôpital Sud
Amiens, France
Radiothérapie, CLCC François Baclesse
Caen, France
Radiothérapie, CRLCC Jean Perrin
Clermont-Ferrand, France
Radiothérapie, CRLCC GF Leclerc
Dijon, France
Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
Grenoble, France
Radiothérapie, CRLCC Oscar Lambret
Lille, France
Radiothérapie, CRLCC Léon Bérard
Lyon, France
Radiothérapie, CRLCC Institut Paoli Calmettes
Marseille, France
Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
Montpellier, France
Pôle de radiothérapie, Centre Antoine-Lacassagne
Nice, France
Radiothérapie, CHU Pitié-Salpétrière
Paris, France
Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
Paris, France
Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
Pessac, France
Radiothérapie, CRLCC Institut Jean Godinot
Reims, France
Centre Eugene Marquis
Rennes, France
Radiothérapie, CRLCC René Gauducheau
Saint-Herblain, France
Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz
Saint-Priest-en-Jarez, France
Radiothérapie, CRLCC Paul Strauss
Strasbourg, France
Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud
Toulouse, France
Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, France
Radiothérapie, Institut Gustave Roussy
Villejuif, France