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Recruiting Not applicable

Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

NCT02838602 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2017-12-23
Last updated
2021-09-02

Condition(s) studied

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

Investigational drug(s) / intervention(s)

Carbon ions therapyAdvanced external radiotherapy by Xrays or protons

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
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
Official registry record

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