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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.
Enrollment
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Inclusion criteria
age ≥ 18 years
No severe comorbidity, life expectancy above 10 years
Unresectable or inoperable or R2 resection of the tumor
Eligible radioresistant tumor according to the limitative list as following:
Absence of epidermal invasion (a hypodermic invasion is accepted with fixity of cutaneous plan but not true epidermal permeation)
Larger volume to be irradiated (PTV) less than 25 cm
ECOG Performance Status ≤ 2 or Karnovsky index ≥ 60
no pregnancy of possibility of pregnancy during the treatment
having an health insurance
signature of a written informed consent
validation of the randomization criteria: namely, a carbon ions therapy indication assessed by the medical team of a hadrontherapy center and able to by treated within two month from registration.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
250 participants in 2 patient groups
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Central trial contact
Pascal POMMIER, MD
Data sourced from clinicaltrials.gov
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