Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
Carbon ions therapy: External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
Advanced external radiotherapy by Xrays or protons: 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
Study 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.
Eligibility
Primary outcome measure(s)
- Progression free survival (PFS) — up to 5 years or loss of follow-up
Starting point for PFS measurement is the randomization date
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux | Pessac | France | Not Yet Recruiting |
| Radiothérapie, CRLCC Institut Jean Godinot | Reims | France | Recruiting |
| Centre Eugene Marquis | Rennes | France | Not Yet Recruiting |
| Radiothérapie, CRLCC René Gauducheau | Saint-Herblain | France | Not Yet Recruiting |
| Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz | Saint-Priest-en-Jarez | France | Recruiting |
| Radiothérapie, CRLCC Paul Strauss | Strasbourg | France | Recruiting |
| Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud | Toulouse | France | Recruiting |
| Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin | Vandœuvre-lès-Nancy | France | Recruiting |
| Radiothérapie, Institut Gustave Roussy | Villejuif | France | Not Yet Recruiting |
More Hospices Civils de Lyon trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02838602 on ClinicalTrials.gov ↗ ← All trials in France