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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
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
CHU Amiens - Hôpital Sud
Amiens, France
RECRUITINGRadiothérapie, CLCC François Baclesse
Caen, France
RECRUITINGRadiothérapie, CRLCC Jean Perrin
Clermont-Ferrand, France
NOT_YET_RECRUITINGRadiothérapie, CRLCC GF Leclerc
Dijon, France
RECRUITINGRadiothérapie, Hôpital A. Michallon, CHU de Grenoble
Grenoble, France
RECRUITINGRadiothérapie, CRLCC Oscar Lambret
Lille, France
RECRUITINGRadiothérapie, CRLCC Léon Bérard
Lyon, France
RECRUITINGRadiothérapie, CRLCC Institut Paoli Calmettes
Marseille, France
NOT_YET_RECRUITINGRadiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
Montpellier, France
RECRUITINGPôle de radiothérapie, Centre Antoine-Lacassagne
Nice, France
RECRUITING...and 11 more locations
Progression free survival (PFS)
Starting point for PFS measurement is the randomization date
Time frame: up to 5 years or loss of follow-up
Grades of the CTCAE-V4.02 classification
Tolerance
Time frame: up to 5 years or loss of follow-up
EQ-5D questionnaire
Quality of life
Time frame: up to 5 years or loss of follow-up
Local progression free survival
takes account of the local progression of the tumor in the planning target volume (PTV)
Time frame: up to 5 years or loss of follow-up
Metastases free survival
takes account of any site of relapse outside of the PTV
Time frame: up to 5 years or loss of follow-up
Overall survival
delay of death of any cause accounted starting from randomization
Time frame: up to 5 years or loss of follow-up
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