Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

NCT ID: NCT02838602

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-23
• Study Completion Date: 2026-12-23

Brief 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.

Conditions

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbon ions therapy

Radical and exclusive carbon ions radiotherapy

Group Type: EXPERIMENTAL

Carbon ions therapy

Intervention Type: RADIATION

External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center

Conventional radiotherapy

Radical radiotherapy by Xrays and / or protons

Group Type: ACTIVE_COMPARATOR

Advanced external radiotherapy by Xrays or protons

Intervention Type: RADIATION

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

Interventions

Carbon ions therapy

External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center

Intervention Type: RADIATION

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal POMMIER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

CHU Amiens - Hôpital Sud

Amiens, , France

Site Status: RECRUITING

Radiothérapie, CLCC François Baclesse

Caen, , France

Site Status: RECRUITING

Radiothérapie, CRLCC Jean Perrin

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

Radiothérapie, CRLCC GF Leclerc

Dijon, , France

Site Status: RECRUITING

Radiothérapie, Hôpital A. Michallon, CHU de Grenoble

Grenoble, , France

Site Status: RECRUITING

Radiothérapie, CRLCC Oscar Lambret

Lille, , France

Site Status: RECRUITING

Radiothérapie, CRLCC Léon Bérard

Lyon, , France

Site Status: RECRUITING

Radiothérapie, CRLCC Institut Paoli Calmettes

Marseille, , France

Site Status: NOT_YET_RECRUITING

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

Montpellier, , France

Site Status: RECRUITING

Pôle de radiothérapie, Centre Antoine-Lacassagne

Nice, , France

Site Status: RECRUITING

Radiothérapie, CHU Pitié-Salpétrière

Paris, , France

Site Status: NOT_YET_RECRUITING

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

Paris, , France

Site Status: NOT_YET_RECRUITING

Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux

Pessac, , France

Site Status: NOT_YET_RECRUITING

Radiothérapie, CRLCC Institut Jean Godinot

Reims, , France

Site Status: RECRUITING

Centre Eugene Marquis

Rennes, , France

Site Status: NOT_YET_RECRUITING

Radiothérapie, CRLCC René Gauducheau

Saint-Herblain, , France

Site Status: NOT_YET_RECRUITING

Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz

Saint-Priest-en-Jarez, , France

Site Status: RECRUITING

Radiothérapie, CRLCC Paul Strauss

Strasbourg, , France

Site Status: RECRUITING

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

Toulouse, , France

Site Status: RECRUITING

Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status: RECRUITING

Radiothérapie, Institut Gustave Roussy

Villejuif, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Pascal POMMIER, MD

Role: CONTACT

pascal.pommier@lyon.unicancer.fr

(0)4 78 78 51 66 ext. +33

Facility Contacts

Claude KRZISCH, MD

Role: primary

Juliette THARIAT, MD

Role: primary

Fanny MARTIN

Role: primary

Gilles TRUC, MD

Role: primary

03.80.73.75.18

Camille, Olivier VERRY, MD

Role: primary

04.76.76.54.35

Xavier MIRABEL, MD

Role: primary

03.20.29.55.98

Pascal POMMIER, MD

Role: primary

pascal.pommier@lyon.unicancer.fr

(0)4 78 78 51 66 ext. +33

Laurence MOUREAU-ZABOTTO, MD

Role: primary

04.91.22.36.37

Pierre BOISSELIER, MD

Role: primary

Alexander FALK, MD

Role: primary

Loïc FEUVRET

Role: primary

01.42.17.81.71

Rémi DENDALE, MD

Role: primary

Charles DUPIN, MD

Role: primary

Stéphanie SERVAGI-VERNAT, MD

Role: primary

Joël CASTELLI, MD

Role: primary

Augustin MERVOYER, MD

Role: primary

02.40.67.99.30

Nicolas MAGNE, MD

Role: primary

Georges NOEL, MD

Role: primary

03.88.25.24.71

Anne DUCASSOU, MD

Role: primary

Guillaume VOGIN, MD

Role: primary

03.83.59.84.27

Cécile LE PECHOUX, MD

Role: primary

01.42.11.42.11

References

Balosso J, Febvey-Combes O, Iung A, Lozano H, Alloh AS, Cornu C, Herve M, Akkal Z, Lievre M, Plattner V, Valvo F, Bono C, Fiore MR, Vitolo V, Vischioni B, Patin S, Allemand H, Gueyffier F, Margier J, Guerre P, Chabaud S, Orecchia R, Pommier P. A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy - including photon and proton therapy - for the treatment of radioresistant tumors: the ETOILE trial. BMC Cancer. 2022 May 23;22(1):575. doi: 10.1186/s12885-022-09564-7.

Reference Type: DERIVED

PMID: 35606739 (View on PubMed)

Other Identifiers

2012-760

Identifier Type: -

Identifier Source: org_study_id