RecruitingNot ApplicableNCT02838602

Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors

Sponsor

Hospices Civils de Lyon

Enrollment

250 participants

Start Date

Dec 23, 2017

Study Type

INTERVENTIONAL

Conditions

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing carbon ion radiation therapy — a newer, more targeted type of radiation — against standard radiation therapy for patients with hard-to-treat tumors that cannot be surgically removed. **You may be eligible if...** - You are 18 years or older with a life expectancy of more than 10 years - Your tumor cannot be safely removed by surgery, or was incompletely removed - Your tumor is one of the specific types included: adenoid cystic carcinoma of the head or neck, soft tissue sarcoma, certain rhabdomyosarcomas, retroperitoneal sarcoma, osteosarcoma, chondrosarcoma, chordoma of the spine or pelvis, or angiosarcoma - You do not have serious coexisting illnesses **You may NOT be eligible if...** - Your tumor type is not on the approved list for this study - The tumor has grown through the skin surface - The cancer has spread to distant parts of the body - You have serious other health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONCarbon ions therapy

External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center

RADIATIONAdvanced 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

Locations(21)

CHU Amiens - Hôpital Sud

Amiens, France

Radiothérapie, CLCC François Baclesse

Caen, France

Radiothérapie, CRLCC Jean Perrin

Clermont-Ferrand, France

Radiothérapie, CRLCC GF Leclerc

Dijon, France

Radiothérapie, Hôpital A. Michallon, CHU de Grenoble

Grenoble, France

Radiothérapie, CRLCC Oscar Lambret

Lille, France

Radiothérapie, CRLCC Léon Bérard

Lyon, France

Radiothérapie, CRLCC Institut Paoli Calmettes

Marseille, France

Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle

Montpellier, France

Pôle de radiothérapie, Centre Antoine-Lacassagne

Nice, France

Radiothérapie, CHU Pitié-Salpétrière

Paris, France

Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)

Paris, France

Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux

Pessac, France

Radiothérapie, CRLCC Institut Jean Godinot

Reims, France

Centre Eugene Marquis

Rennes, France

Radiothérapie, CRLCC René Gauducheau

Saint-Herblain, France

Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz

Saint-Priest-en-Jarez, France

Radiothérapie, CRLCC Paul Strauss

Strasbourg, France

Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud

Toulouse, France

Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, France

Radiothérapie, Institut Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02838602