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Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors (ETOILE)

Primary Purpose

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Carbon ions therapy

Advanced external radiotherapy by Xrays or protons

About this trial

This is an interventional treatment trial for Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma focused on measuring carbon ions therapy, radiotherapy, radioresistant tumors, cancer, randomized trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Amiens - Hôpital SudRecruiting
Radiothérapie, CLCC François BaclesseRecruiting
Radiothérapie, CRLCC Jean Perrin
Radiothérapie, CRLCC GF LeclercRecruiting
Radiothérapie, Hôpital A. Michallon, CHU de GrenobleRecruiting
Radiothérapie, CRLCC Oscar LambretRecruiting
Radiothérapie, CRLCC Léon BérardRecruiting
Radiothérapie, CRLCC Institut Paoli Calmettes
Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'AurelleRecruiting
Pôle de radiothérapie, Centre Antoine-LacassagneRecruiting
Radiothérapie, CHU Pitié-Salpétrière
Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
Radiothérapie, CRLCC Institut Jean GodinotRecruiting
Centre Eugene Marquis
Radiothérapie, CRLCC René Gauducheau
Radiothérapie, Institut de Cancérologie de la Loire Lucien NeuwirtzRecruiting
Radiothérapie, CRLCC Paul StraussRecruiting
Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius RegaudRecruiting
Radiothérapie, Institut de Cancérologie de Lorraine Alexis VautrinRecruiting
Radiothérapie, Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbon ions therapy

Conventional radiotherapy

Arm Description

Radical and exclusive carbon ions radiotherapy

Radical radiotherapy by Xrays and / or protons

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Starting point for PFS measurement is the randomization date

Secondary Outcome Measures

Grades of the CTCAE-V4.02 classification

Tolerance

EQ-5D questionnaire

Quality of life

Local progression free survival

takes account of the local progression of the tumor in the planning target volume (PTV)

Metastases free survival

takes account of any site of relapse outside of the PTV

Overall survival

delay of death of any cause accounted starting from randomization

Full Information

NCT ID

NCT02838602

First Posted

July 18, 2016

Last Updated

September 1, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT02838602

Brief Title

Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

Acronym

ETOILE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 23, 2017 (Actual)

Primary Completion Date

December 23, 2026 (Anticipated)

Study Completion Date

December 23, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma

Keywords

carbon ions therapy, radiotherapy, radioresistant tumors, cancer, randomized trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carbon ions therapy

Arm Type

Experimental

Arm Description

Radical and exclusive carbon ions radiotherapy

Arm Title

Conventional radiotherapy

Arm Type

Active Comparator

Arm Description

Radical radiotherapy by Xrays and / or protons

Intervention Type

Radiation

Intervention Name(s)

Carbon ions therapy

Intervention Description

External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center

Intervention Type

Radiation

Intervention Name(s)

Advanced external radiotherapy by Xrays or protons

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Starting point for PFS measurement is the randomization date

Time Frame

up to 5 years or loss of follow-up

Secondary Outcome Measure Information:

Title

Grades of the CTCAE-V4.02 classification

Description

Tolerance

Time Frame

up to 5 years or loss of follow-up

Title

EQ-5D questionnaire

Description

Quality of life

Time Frame

up to 5 years or loss of follow-up

Title

Local progression free survival

Description

takes account of the local progression of the tumor in the planning target volume (PTV)

Time Frame

up to 5 years or loss of follow-up

Title

Metastases free survival

Description

takes account of any site of relapse outside of the PTV

Time Frame

up to 5 years or loss of follow-up

Title

Overall survival

Description

delay of death of any cause accounted starting from randomization

Time Frame

up to 5 years or loss of follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal POMMIER, MD

Phone

(0)4 78 78 51 66

Ext

+33

pascal.pommier@lyon.unicancer.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal POMMIER, MD

Organizational Affiliation

Centre Leon Berard

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens - Hôpital Sud

City

Amiens

ZIP/Postal Code

80054

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claude KRZISCH, MD

First Name & Middle Initial & Last Name & Degree

Claude KRZISCH, MD

Facility Name

Radiothérapie, CLCC François Baclesse

City

Caen

ZIP/Postal Code

14076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juliette THARIAT, MD

First Name & Middle Initial & Last Name & Degree

Juliette THARIAT, MD

First Name & Middle Initial & Last Name & Degree

Dinu STEFAN, MD

First Name & Middle Initial & Last Name & Degree

Delphine LEROUGE, MD

First Name & Middle Initial & Last Name & Degree

Bernard GERY, MD

First Name & Middle Initial & Last Name & Degree

Laura MOISE, MD

First Name & Middle Initial & Last Name & Degree

Sabine NOAL, MD

First Name & Middle Initial & Last Name & Degree

Jacques BALOSSO, MD

Facility Name

Radiothérapie, CRLCC Jean Perrin

City

Clermont-Ferrand

ZIP/Postal Code

63011

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fanny MARTIN

First Name & Middle Initial & Last Name & Degree

Fanny MARTIN, MD

First Name & Middle Initial & Last Name & Degree

Michel LAPEYRE, MD

First Name & Middle Initial & Last Name & Degree

Jessica MIROIR, MD

Facility Name

Radiothérapie, CRLCC GF Leclerc

City

Dijon

ZIP/Postal Code

21034

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilles TRUC, MD

Phone

03.80.73.75.18

First Name & Middle Initial & Last Name & Degree

Gilles TRUC, MD

First Name & Middle Initial & Last Name & Degree

Noémie VULQUIN, MD

First Name & Middle Initial & Last Name & Degree

David THIBOUW, MD

First Name & Middle Initial & Last Name & Degree

Caroline AMOYAL, MD

Facility Name

Radiothérapie, Hôpital A. Michallon, CHU de Grenoble

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Camille, Olivier VERRY, MD

Phone

04.76.76.54.35

First Name & Middle Initial & Last Name & Degree

Camille, Olivier VERRY, MD

First Name & Middle Initial & Last Name & Degree

Julie VILLA, MD

First Name & Middle Initial & Last Name & Degree

Jacques BALOSSO, MD

First Name & Middle Initial & Last Name & Degree

Carole IRIART, MD

First Name & Middle Initial & Last Name & Degree

Violaine BRUN-BARONNAT, MD

Facility Name

Radiothérapie, CRLCC Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xavier MIRABEL, MD

Phone

03.20.29.55.98

First Name & Middle Initial & Last Name & Degree

Xavier MIRABEL, MD

First Name & Middle Initial & Last Name & Degree

Raphaëlle MOUTTET-AUDOUARD, MD

First Name & Middle Initial & Last Name & Degree

Abel CORDOBA, MD

First Name & Middle Initial & Last Name & Degree

Xavier LIEM, MD

First Name & Middle Initial & Last Name & Degree

David PASQUIER, MD

Facility Name

Radiothérapie, CRLCC Léon Bérard

City

Lyon

ZIP/Postal Code

69373

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal POMMIER, MD

Phone

(0)4 78 78 51 66

Ext

+33

pascal.pommier@lyon.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Pascal POMMIER, MD

First Name & Middle Initial & Last Name & Degree

Marie-Pierre SUNYACH, MD

First Name & Middle Initial & Last Name & Degree

Vincent GREGOIRE, MD

Facility Name

Radiothérapie, CRLCC Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence MOUREAU-ZABOTTO, MD

Phone

04.91.22.36.37

First Name & Middle Initial & Last Name & Degree

Laurence MOUREAU-ZABOTTO, MD

Facility Name

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

City

Montpellier

ZIP/Postal Code

34298

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre BOISSELIER, MD

First Name & Middle Initial & Last Name & Degree

Pierre BOISSELIER, MD

Facility Name

Pôle de radiothérapie, Centre Antoine-Lacassagne

City

Nice

ZIP/Postal Code

06189

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander FALK, MD

First Name & Middle Initial & Last Name & Degree

Alexander FALK, MD

First Name & Middle Initial & Last Name & Degree

Jérôme DOYEN, MD

First Name & Middle Initial & Last Name & Degree

Pierre-Yves BONDIAU, MD

First Name & Middle Initial & Last Name & Degree

Karen BENEZERY, MD

Facility Name

Radiothérapie, CHU Pitié-Salpétrière

City

Paris

ZIP/Postal Code

75013

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Loïc FEUVRET

Phone

01.42.17.81.71

First Name & Middle Initial & Last Name & Degree

Loïc FEUVRET, MD

Facility Name

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

City

Paris

ZIP/Postal Code

75231

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rémi DENDALE, MD

First Name & Middle Initial & Last Name & Degree

Rémi DENDALE, MD

First Name & Middle Initial & Last Name & Degree

Claire ALAPETITE, MD

Facility Name

Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux

City

Pessac

ZIP/Postal Code

33604

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charles DUPIN, MD

First Name & Middle Initial & Last Name & Degree

Charles DUPIN, MD

First Name & Middle Initial & Last Name & Degree

Huchet AYMERI, MD

Facility Name

Radiothérapie, CRLCC Institut Jean Godinot

City

Reims

ZIP/Postal Code

51726

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphanie SERVAGI-VERNAT, MD

First Name & Middle Initial & Last Name & Degree

Stéphanie SERVAGI-VERNAT, MD

Facility Name

Centre Eugene Marquis

City

Rennes

ZIP/Postal Code

35000

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joël CASTELLI, MD

First Name & Middle Initial & Last Name & Degree

Joël CASTELLI, MD

Facility Name

Radiothérapie, CRLCC René Gauducheau

City

Saint-Herblain

ZIP/Postal Code

44805

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Augustin MERVOYER, MD

Phone

02.40.67.99.30

First Name & Middle Initial & Last Name & Degree

Augustin MERVOYER, MD

First Name & Middle Initial & Last Name & Degree

Nadia WIAZZANE, MD

Facility Name

Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz

City

St Priest en Jarez

ZIP/Postal Code

42270

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas MAGNE, MD

First Name & Middle Initial & Last Name & Degree

Nicolas MAGNE, MD

First Name & Middle Initial & Last Name & Degree

Amel REHAILIA-BLANCHARD, MD

First Name & Middle Initial & Last Name & Degree

Grégoire PIGNE, MD

Facility Name

Radiothérapie, CRLCC Paul Strauss

City

Strasbourg

ZIP/Postal Code

67065

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georges NOEL, MD

Phone

03.88.25.24.71

First Name & Middle Initial & Last Name & Degree

Georges NOEL, MD

Facility Name

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

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne DUCASSOU, MD

First Name & Middle Initial & Last Name & Degree

Anne DUCASSOU, MD

First Name & Middle Initial & Last Name & Degree

Anne LAPRIE, MD

First Name & Middle Initial & Last Name & Degree

Martine DELANNES, MD

Facility Name

Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin

City

Vandœuvre-lès-Nancy

ZIP/Postal Code

54500

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guillaume VOGIN, MD

Phone

03.83.59.84.27

First Name & Middle Initial & Last Name & Degree

Guillaume VOGIN, MD

First Name & Middle Initial & Last Name & Degree

Sophie RENARD, MD

Facility Name

Radiothérapie, Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cécile LE PECHOUX, MD

Phone

01.42.11.42.11

First Name & Middle Initial & Last Name & Degree

Cécile LE PECHOUX, MD

First Name & Middle Initial & Last Name & Degree

Stéphanie BOLLE, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35606739

Citation

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.

Results Reference

derived

Learn more about this trial

Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors

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