Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

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:
• adenoid cystic carcinoma of head and neck (larynx and trachea excluded)
• soft tissue sarcoma
• pleomorphic rhabdomyosarcoma only (alveolar and embryonal forms excluded)
• retroperitoneal sarcoma under condition of technical feasibility (movement)
• osteosarcoma of any grade and localisation (Ewing excluded)
• chondrosarcoma (except of skull base) OMS grade >= 2
• chordoma axial skeleton or pelvis (except of skull base)
• angiosarcoma
• Absence of epidermal invasion (a hypodermic invasion is accepted with fixity ofcutaneous 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 indicationassessed by the medical team of a hadrontherapy center and able to by treated withintwo month from registration.

Exclusion Criteria:

• Complete macroscopic or microscopic surgical resection (R0 or R1)
• previous irradiation in the volume to be treated
• metastatic disease
• disease not candidate to a curative approach (example accelerated progressivediseaseresistant to nay medical treatment especially for sarcoma)
• any contra-indication to undergo a radiation therapy by Xray or particle therapy
• planned surgery or chemotherapy to take place after completion of radiotherapy (example : absence of enough space between an organ risk and the target volume (atleast 5 mm) except the possibility of a spacer insertion)
• planned surgery or chemotherapy after radiotherapy
• Presence in the target volume of metallic material which cannot be removed (carbonfibres matreial authorized)
• history of concomittant (except in situ cervix carcinoma; or any cured basocellularcutaneous cancer tor any cured cancer with no sign of relapse during 5 years))
• impossible follow-up over 5 years