Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-09 @ 5:35 AM
Study NCT ID:
NCT02838602
Status:
RECRUITING
Last Update Posted:
2021-09-02
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003528', 'term': 'Carcinoma, Adenoid Cystic'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011522', 'term': 'Protons'}], 'ancestors': [{'id': 'D002414', 'term': 'Cations, Monovalent'}, {'id': 'D002412', 'term': 'Cations'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006859', 'term': 'Hydrogen'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D000071940', 'term': 'Nucleons'}, {'id': 'D004601', 'term': 'Elementary Particles'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'up to 5 years or loss of follow-up', 'description': 'Starting point for PFS measurement is the randomization date'}], 'secondaryOutcomes': [{'measure': 'Grades of the CTCAE-V4.02 classification', 'timeFrame': 'up to 5 years or loss of follow-up', 'description': 'Tolerance'}, {'measure': 'EQ-5D questionnaire', 'timeFrame': 'up to 5 years or loss of follow-up', 'description': 'Quality of life'}, {'measure': 'Local progression free survival', 'timeFrame': 'up to 5 years or loss of follow-up', 'description': 'takes account of the local progression of the tumor in the planning target volume (PTV)'}, {'measure': 'Metastases free survival', 'timeFrame': 'up to 5 years or loss of follow-up', 'description': 'takes account of any site of relapse outside of the PTV'}, {'measure': 'Overall survival', 'timeFrame': 'up to 5 years or loss of follow-up', 'description': 'delay of death of any cause accounted starting from randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carbon ions therapy', 'radiotherapy', 'radioresistant tumors', 'cancer', 'randomized trial'], 'conditions': ['Malignant Tumors as Chordoma, Adenoid Cystic Carcinoma and Sarcoma']}, 'referencesModule': {'references': [{'pmid': '35606739', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18 years\n* No severe comorbidity, life expectancy above 10 years\n* Unresectable or inoperable or R2 resection of the tumor\n* Eligible radioresistant tumor according to the limitative list as following:\n\n * adenoid cystic carcinoma of head and neck (larynx and trachea excluded)\n * soft tissue sarcoma\n * pleomorphic rhabdomyosarcoma only (alveolar and embryonal forms excluded)\n * retroperitoneal sarcoma under condition of technical feasibility (movement)\n * osteosarcoma of any grade and localisation (Ewing excluded)\n * chondrosarcoma (except of skull base) OMS grade \\>= 2\n * chordoma axial skeleton or pelvis (except of skull base)\n * angiosarcoma\n* Absence of epidermal invasion (a hypodermic invasion is accepted with fixity of cutaneous plan but not true epidermal permeation)\n* Larger volume to be irradiated (PTV) less than 25 cm\n* ECOG Performance Status ≤ 2 or Karnovsky index ≥ 60\n* no pregnancy of possibility of pregnancy during the treatment\n* having an health insurance\n* signature of a written informed consent\n* 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.\n\nExclusion Criteria:\n\n* Complete macroscopic or microscopic surgical resection (R0 or R1)\n* previous irradiation in the volume to be treated\n* metastatic disease\n* disease not candidate to a curative approach (example accelerated progressive diseaseresistant to nay medical treatment especially for sarcoma)\n* any contra-indication to undergo a radiation therapy by Xray or particle therapy\n* 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)\n* planned surgery or chemotherapy after radiotherapy\n* Presence in the target volume of metallic material which cannot be removed (carbon fibres matreial authorized)\n* 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))\n* impossible follow-up over 5 years'}, 'identificationModule': {'nctId': 'NCT02838602', 'acronym': 'ETOILE', 'briefTitle': 'Randomized Carbon Ions vs Standard Radiotherapy for Radioresistant Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors', 'orgStudyIdInfo': {'id': '2012-760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbon ions therapy', 'description': 'Radical and exclusive carbon ions radiotherapy', 'interventionNames': ['Radiation: Carbon ions therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional radiotherapy', 'description': 'Radical radiotherapy by Xrays and / or protons', 'interventionNames': ['Radiation: Advanced external radiotherapy by Xrays or protons']}], 'interventions': [{'name': 'Carbon ions therapy', 'type': 'RADIATION', 'description': 'External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center', 'armGroupLabels': ['Carbon ions therapy']}, {'name': 'Advanced external radiotherapy by Xrays or protons', 'type': 'RADIATION', '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', 'armGroupLabels': ['Conventional radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claude KRZISCH, MD', 'role': 'CONTACT'}, {'name': 'Claude KRZISCH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Amiens - Hôpital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '14076', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Juliette THARIAT, MD', 'role': 'CONTACT'}, {'name': 'Juliette THARIAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dinu STEFAN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Delphine LEROUGE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bernard GERY, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura MOISE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sabine NOAL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jacques BALOSSO, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, CLCC François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fanny MARTIN', 'role': 'CONTACT'}, {'name': 'Fanny MARTIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michel LAPEYRE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jessica MIROIR, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21034', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles TRUC, MD', 'role': 'CONTACT', 'phone': '03.80.73.75.18'}, {'name': 'Gilles TRUC, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Noémie VULQUIN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David THIBOUW, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline AMOYAL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC GF Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Camille, Olivier VERRY, MD', 'role': 'CONTACT', 'phone': '04.76.76.54.35'}, {'name': 'Camille, Olivier VERRY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julie VILLA, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jacques BALOSSO, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carole IRIART, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Violaine BRUN-BARONNAT, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, Hôpital A. Michallon, CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59020', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier MIRABEL, MD', 'role': 'CONTACT', 'phone': '03.20.29.55.98'}, {'name': 'Xavier MIRABEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raphaëlle MOUTTET-AUDOUARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abel CORDOBA, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xavier LIEM, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David PASQUIER, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal POMMIER, MD', 'role': 'CONTACT', 'email': 'pascal.pommier@lyon.unicancer.fr', 'phone': '(0)4 78 78 51 66', 'phoneExt': '+33'}, {'name': 'Pascal POMMIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie-Pierre SUNYACH, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vincent GREGOIRE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13009', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence MOUREAU-ZABOTTO, MD', 'role': 'CONTACT', 'phone': '04.91.22.36.37'}, {'name': 'Laurence MOUREAU-ZABOTTO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre BOISSELIER, MD', 'role': 'CONTACT'}, {'name': 'Pierre BOISSELIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06189', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexander FALK, MD', 'role': 'CONTACT'}, {'name': 'Alexander FALK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jérôme DOYEN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre-Yves BONDIAU, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karen BENEZERY, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Pôle de radiothérapie, Centre Antoine-Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Loïc FEUVRET', 'role': 'CONTACT', 'phone': '01.42.17.81.71'}, {'name': 'Loïc FEUVRET, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiothérapie, CHU Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75231', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rémi DENDALE, MD', 'role': 'CONTACT'}, {'name': 'Rémi DENDALE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claire ALAPETITE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles DUPIN, MD', 'role': 'CONTACT'}, {'name': 'Charles DUPIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huchet AYMERI, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '51726', 'city': 'Reims', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie SERVAGI-VERNAT, MD', 'role': 'CONTACT'}, {'name': 'Stéphanie SERVAGI-VERNAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC Institut Jean Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35000', 'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Joël CASTELLI, MD', 'role': 'CONTACT'}, {'name': 'Joël CASTELLI, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44805', 'city': 'Saint-Herblain', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Augustin MERVOYER, MD', 'role': 'CONTACT', 'phone': '02.40.67.99.30'}, {'name': 'Augustin MERVOYER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nadia WIAZZANE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC René Gauducheau', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas MAGNE, MD', 'role': 'CONTACT'}, {'name': 'Nicolas MAGNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amel REHAILIA-BLANCHARD, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Grégoire PIGNE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '67065', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Georges NOEL, MD', 'role': 'CONTACT', 'phone': '03.88.25.24.71'}, {'name': 'Georges NOEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiothérapie, CRLCC Paul Strauss', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne DUCASSOU, MD', 'role': 'CONTACT'}, {'name': 'Anne DUCASSOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anne LAPRIE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martine DELANNES, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume VOGIN, MD', 'role': 'CONTACT', 'phone': '03.83.59.84.27'}, {'name': 'Guillaume VOGIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sophie RENARD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile LE PECHOUX, MD', 'role': 'CONTACT', 'phone': '01.42.11.42.11'}, {'name': 'Cécile LE PECHOUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Stéphanie BOLLE, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Radiothérapie, Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Pascal POMMIER, MD', 'role': 'CONTACT', 'email': 'pascal.pommier@lyon.unicancer.fr', 'phone': '(0)4 78 78 51 66', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Pascal POMMIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}