Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

Launched by HOSPICES CIVILS DE LYON · Jul 18, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of carbon ion therapy compared to standard radiation treatments (like photon or proton therapy) for patients with specific types of difficult-to-treat malignant tumors, including certain types of chordomas, adenoid cystic carcinomas, and sarcomas. The goal is to see if carbon ion therapy can help patients live longer without their cancer returning, particularly after five years. The trial is looking for 250 participants who are adults aged 18 and older, have tumors that cannot be removed by surgery, and meet other specific health criteria.

If you join the trial, you will be randomly assigned to either the carbon ion treatment group or the standard radiation group, with the treatments being provided at specialized centers in Europe or France. Throughout the trial, researchers will monitor your health and the effectiveness of the treatments. This study is supported by the French healthcare system, and it also includes additional studies to understand how these tumors respond to the treatments and their economic impact. If you think this trial might be right for you or a loved one, it’s important to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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 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:
• • 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 progressive diseaseresistant 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 (at least 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 (carbon fibres matreial authorized)
• • history of concomittant (except in situ cervix carcinoma; or any cured basocellular cutaneous cancer tor any cured cancer with no sign of relapse during 5 years))
• • impossible follow-up over 5 years