Condition: Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma · Sponsor: Hospices Civils de Lyon
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.
This description comes directly from the study's public registry record.
Pascal POMMIER, MD · (0)4 78 78 51 66 · pascal.pommier@lyon.unicancer.fr
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| CHU Amiens - Hôpital Sud | Amiens, France | Recruiting |
| Radiothérapie, CLCC François Baclesse | Caen, France | Recruiting |
| Radiothérapie, CRLCC Jean Perrin | Clermont-Ferrand, France | Not Yet Recruiting |
| Radiothérapie, CRLCC GF Leclerc | Dijon, France | Recruiting |
| Radiothérapie, Hôpital A. Michallon, CHU de Grenoble | Grenoble, France | Recruiting |
| Radiothérapie, CRLCC Oscar Lambret | Lille, France | Recruiting |
| Radiothérapie, CRLCC Léon Bérard | Lyon, France | Recruiting |
| Radiothérapie, CRLCC Institut Paoli Calmettes | Marseille, France | Not Yet Recruiting |
| Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle | Montpellier, France | Recruiting |
| Pôle de radiothérapie, Centre Antoine-Lacassagne | Nice, France | Recruiting |
| Radiothérapie, CHU Pitié-Salpétrière | Paris, France | Not Yet Recruiting |
| Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie) | Paris, France | Not Yet Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02838602