At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Unresectable, inoperable, or R2 resection of tumor
- ✓Adenoid cystic carcinoma of head and neck (excluding larynx and trachea)
- ✓Soft tissue sarcoma
- ✕Complete macroscopic or microscopic surgical resection (R0 or R1)
- ✕Prior irradiation in the treatment volume
- ✕Metastatic disease
- ✕Disease not candidate for curative approach
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors
In Brief
A clinical study evaluating Carbon ions therapy and Advanced external radiotherapy by Xrays or protons for Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma. Currently recruiting, targeting 250 participants across 21 sites.
Detailed 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.
Study Details
Timeline
Interventions
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