Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and SarcomaETOILENCT02838602
Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
A study testing Carbon ions therapy and Advanced external radiotherapy by Xrays or protons in people with Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma, run by Hospices Civils de Lyon at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma
- What is being tested?
- Carbon ions therapy and Advanced external radiotherapy by Xrays or protons
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 21 sitesFrance
- Study dates
- 23 Dec 2017to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
France21 sites, 21 recruiting
- Recruiting
CHU Amiens - Hôpital Sud
Amiens, 80054
Claude KRZISCH, MD
Claude KRZISCH, MD
- Recruiting
Radiothérapie, CLCC François Baclesse
Caen, 14076
Juliette THARIAT, MD
Juliette THARIAT, MD
- Not yet recruiting
Radiothérapie, CRLCC Jean Perrin
Clermont-Ferrand, 63011
Fanny MARTIN
Fanny MARTIN, MD
- Recruiting
Radiothérapie, CRLCC GF Leclerc
Dijon, 21034
Gilles TRUC, MD, 03.80.73.75.18
Gilles TRUC, MD
- Recruiting
Radiothérapie, Hôpital A. Michallon, CHU de Grenoble
Grenoble, 38043
Camille, Olivier VERRY, MD, 04.76.76.54.35
Camille, Olivier VERRY, MD
- Recruiting
Radiothérapie, CRLCC Oscar Lambret
Lille, 59020
Xavier MIRABEL, MD, 03.20.29.55.98
Xavier MIRABEL, MD
- Recruiting
Radiothérapie, CRLCC Léon Bérard
Lyon, 69373
Pascal POMMIER, MD, (0)4 78 78 51 66 ext. +33, pascal.pommier@lyon.unicancer.fr
Pascal POMMIER, MD
- Not yet recruiting
Radiothérapie, CRLCC Institut Paoli Calmettes
Marseille, 13009
Laurence MOUREAU-ZABOTTO, MD, 04.91.22.36.37
Laurence MOUREAU-ZABOTTO, MD
- Recruiting
Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle
Montpellier, 34298
Pierre BOISSELIER, MD
Pierre BOISSELIER, MD
- Recruiting
Pôle de radiothérapie, Centre Antoine-Lacassagne
Nice, 06189
Alexander FALK, MD
Alexander FALK, MD
- Not yet recruiting
Radiothérapie, CHU Pitié-Salpétrière
Paris, 75013
Loïc FEUVRET, 01.42.17.81.71
Loïc FEUVRET, MD
- Not yet recruiting
Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)
Paris, 75231
Rémi DENDALE, MD
Rémi DENDALE, MD
- Not yet recruiting
Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux
Pessac, 33604
Charles DUPIN, MD
Charles DUPIN, MD
- Recruiting
Radiothérapie, CRLCC Institut Jean Godinot
Reims, 51726
Stéphanie SERVAGI-VERNAT, MD
Stéphanie SERVAGI-VERNAT, MD
- Not yet recruiting
Centre Eugene Marquis
Rennes, 35000
Joël CASTELLI, MD
Joël CASTELLI, MD
- Not yet recruiting
Radiothérapie, CRLCC René Gauducheau
Saint-Herblain, 44805
Augustin MERVOYER, MD, 02.40.67.99.30
Augustin MERVOYER, MD
- Recruiting
Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz
Saint-Priest-en-Jarez, 42270
Nicolas MAGNE, MD
Nicolas MAGNE, MD
- Recruiting
Radiothérapie, CRLCC Paul Strauss
Strasbourg, 67065
Georges NOEL, MD, 03.88.25.24.71
Georges NOEL, MD
- Recruiting
Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud
Toulouse, 31059
Anne DUCASSOU, MD
Anne DUCASSOU, MD
- Recruiting
Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy, 54500
Guillaume VOGIN, MD, 03.83.59.84.27
Guillaume VOGIN, MD
- Not yet recruiting
Radiothérapie, Institut Gustave Roussy
Villejuif, 94805
Cécile LE PECHOUX, MD, 01.42.11.42.11
Cécile LE PECHOUX, MD
About this study
Official title: Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors
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.
- Being tested
- Carbon ions therapy, Advanced external radiotherapy by Xrays or protons
- Keywords
- carbon ions therapy, radiotherapy, radioresistant tumors, cancer, randomized trial
- Medical subject headings
- Carcinoma, Adenoid Cystic, Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon ions therapyRadiation
External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
Advanced external radiotherapy by Xrays or protonsRadiation
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 group | Role | What they receive |
|---|---|---|
| Carbon ions therapy | Experimental | Radical and exclusive carbon ions radiotherapy Receives: Radiation: Carbon ions therapy |
| Conventional radiotherapy | Active comparator | Radical radiotherapy by Xrays and / or protons Receives: Radiation: Advanced external radiotherapy by Xrays or protons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Starting point for PFS measurement is the randomization date
Measured: up to 5 years or loss of follow-up
Secondary outcomes (5)
Grades of the CTCAE-V4.02 classification
Tolerance
Measured: up to 5 years or loss of follow-up
EQ-5D questionnaire
Quality of life
Measured: up to 5 years or loss of follow-up
Local progression free survival
takes account of the local progression of the tumor in the planning target volume (PTV)
Measured: up to 5 years or loss of follow-up
Metastases free survival
takes account of any site of relapse outside of the PTV
Measured: up to 5 years or loss of follow-up
Overall survival
delay of death of any cause accounted starting from randomization
Measured: up to 5 years or loss of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start23 Dec 2017
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and SarcomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal POMMIER, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838602
- Sponsor's protocol ID
- 2012-760
- Acronym
- ETOILE
- Status last verified
- Sep 2021
- First submitted
- 18 Jul 2016
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35606739
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors
- ClinicalTrials.gov ID
- NCT02838602
- Acronym / sponsor ID
- ETOILE / 2012-760
- Keywords
- carbon ions therapy, radiotherapy, radioresistant tumors, cancer, randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon ions therapy | Experimental | Radiation: Carbon ions therapyRadical and exclusive carbon ions radiotherapy |
| Conventional radiotherapy | Active comparator | Radiation: Advanced external radiotherapy by Xrays or protonsRadical radiotherapy by Xrays and / or protons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- Absence of epidermal invasion (a hypodermic invasion is accepted with fixity of cutaneous plan but not true epidermal permeation)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon ions therapyExternal radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center | Radiation | Carbon ions therapy |
| Advanced external radiotherapy by Xrays or protonsRadiotherapy 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 | Radiation | Conventional radiotherapy |
Primary outcome
Progression free survival (PFS)
Time frame: up to 5 years or loss of follow-up
Starting point for PFS measurement is the randomization date
5 secondary outcomes
Grades of the CTCAE-V4.02 classification
Time frame: up to 5 years or loss of follow-up
EQ-5D questionnaire
Time frame: up to 5 years or loss of follow-up
Local progression free survival
Time frame: up to 5 years or loss of follow-up
Metastases free survival
Time frame: up to 5 years or loss of follow-up
Overall survival
Time frame: up to 5 years or loss of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 35606739Balosso 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal POMMIER, MD principal investigator
Centre Leon Berard
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon ions therapy and Advanced external radiotherapy by Xrays or protons in people with Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma, run by Hospices Civils de Lyon at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal POMMIER, MD ((0)4 78 78 51 66 ext. +33, pascal.pommier@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: up to 5 years or loss of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.