Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-01 @ 2:23 AM
Study NCT ID:
NCT06692556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018714', 'term': 'Radiotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients will be randomized (ratio 1:1) using an online platform into one of the two study arms:\n\n* "Adjuvant radiotherapy" arm (=133),\n* "Surveillance" arm (n=133)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 266}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression-free survival after local recurrence salvage therapy in the Surveillance group', 'timeFrame': 'Up to 54 months'}], 'primaryOutcomes': [{'measure': 'Disease-Free Survival (DFS)', 'timeFrame': 'Up to 54 months', 'description': 'DFS is defined as the time from the date of randomization to the date of recurrence (local, lymph node or metastatic) or death from any cause. A new skin lesion will not be considered a statistical event. Patients without an event at the date of analysis will be censored at the last date of new disease-free status.\n\nDFS will be estimated by the Kaplan Meier method and described in terms of median in each arm. DFS distributions will be compared between arms using a Log-Rank test. The hazard ratio from a Cox model will be calculated and presented with its 95% confidence interval. The rate of patients without recurrence at 1 and 2 years post-randomization will also be presented with their associated confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Local recurrence-free survival (lrFS)', 'timeFrame': 'Up to 54 months', 'description': 'lrFS is defined as the time elapsed between the date of randomization and the date of metastatic recurrence or death from any cause. Patients without events at the analysis date will be censored at the last date of news without local disease. Death or metastatic recurrence will be considered as competing events.'}, {'measure': 'Metastatic recurrence-free survival (mFS)', 'timeFrame': 'Up to 54 months', 'description': 'mFS is defined as the time elapsed between the date of randomization and the date of metastatic recurrence or death from any cause. Patients without an event at the analysis date will be censored at the last date of news without metastatic disease.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 54 months', 'description': 'OS is defined as the time from the date of randomization to the date of death from any cause. Patients without an event at the analysis date will be censored at the last date of death-free news.'}, {'measure': 'Tolerance/toxicity', 'timeFrame': 'Up to 54 months', 'description': 'The safety will be described according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTC AE) Version 5 grid by reporting the number and percentage of patients with toxicity by grade. Adverse events will be coded according to the MedDRA® dictionary and will be described by System Organ Class and Preferred Term. The number of patients with at least one AE by grade, at least one AE related to treatment, at least one serious AE (according to pharmacovigilance), at least one serious AE related to treatment will be described by treatment arm. A listing of serious AEs will be published'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': 'Up to 54 months', 'description': 'QoL, will be assessed using the EORTC QLQ-C30 and the EORTC QLQ-ELD14 for the patients ≥ 75 years of age. The difference between the scores at inclusion and during follow-up will be calculated per patient. A difference of 10 points on each score will be considered clinically relevant. A graphic representation in the form of a spider plot will allow to globally visualize the evolution on all the items between the different measurement times.'}, {'measure': 'Interest of radiotherapy in the subgroup of patients over 75 years old', 'timeFrame': 'Up to 54 months', 'description': 'Due to the stratification, the aged population will be well distributed in a balanced way between the treatment arms. The main efficacy criterion and quality of life of this subpopulation will be studied in more detail.'}, {'measure': 'Interest of radiotherapy in the subgroup of patients with Perineural Neoplastic Invasion (PNI)', 'timeFrame': 'Up to 54 months', 'description': 'Due to the stratification, the population with PNI will be well balanced among the treatment arms. The main efficacy criterion and quality of life of this subpopulation will be studied in more detail.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Squamous cell carcinomas at high risk of recurrence', 'Adjuvant radiotherapy', 'Surveillance', 'Peri Nervous System Sheathing'], 'conditions': ['Cutaneous Squamous Cell Carcinoma (CSCC)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC).\n\nThe investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC.\n\nThe main question it aims to answer is:\n\nIs DFS different between the "adjuvant radiotherapy" group and the "surveillance" group?\n\nParticipants will:\n\n* be distributed in one of the two arms\n* will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire)\n* followed up until their death or their progression whether local, regional or metastatic', 'detailedDescription': 'The use of adjuvant radiotherapy appears to provide clinical benefit, both theoretically and based on available retrospective data. This is why some patients already benefit from this complementary treatment. However, given the lack of prospective data, the use of adjuvant radiotherapy is based on heterogeneous criteria, depending on the choice of the clinician in charge of the patient or the habits of his institution.\n\nThe sponsor team therefore propose to conduct a national prospective study to compare the efficacy and safety of a strategy integrating adjuvant radiotherapy versus a strategy based on surveillance in patients with SCC at high risk of recurrence.\n\nConsidering that there is no validated standard after surgery for patients with a high risk of recurrence, it is not possible to determine a standard arm and an experimental arm. This study therefore falls within the framework of a Research Involving the Human Person of Category 2.\n\nThis protocol constitutes the first prospective evaluation of adjuvant radiotherapy, within the framework of a comparative study. This study will thus make it possible to avoid the use of this therapeutic alternative, without rigorous evaluation in a prospective framework. Its robust methodology will make it possible to determine whether adjuvant radiotherapy provides a clinical benefit to patients at high risk of recurrence. It will modify the standards of care for this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age at the time of signing informed consent to participate;\n* Patient with histologically confirmed, localized skin squamous cell carcinoma; Note bene: patients with carcinoma of the external auditory canal may be included in the study;\n* Patient treated with complete excision surgery (R0), regardless of margin (inframillimetric or supramillimetric);\n* High risk disease defined by: presence of a microscopic PNI without/with another risk factor (among those mentioned below) OR presence of 2-3 risk factors other than microscopic PNI; Note Bene: The risk factors selected are immunosuppression (only haematopathy with or without treatment) , a tumor diameter \\>20mm, specific location (lip/ear/temple), deep invasion (thickness \\>6mm or invasion beyond subcutaneous fat), low differentiation or desmoplasia;\n* Patient informed and having signed consent to participate in the study;\n* Patient affiliated with a health insurance plan (or beneficiary of such a plan).\n\nExclusion Criteria:\n\n* Patient with in situ or mixed SCC;\n* History of SCC at high risk of relapse in the same territory (head and neck, trunk or limb) in the 2 years preceding the date of randomization;\n* History of SCC having received systemic treatment;\n* Patient with SCC located in the endonasal, intra-oral, anogenital or vulvar mucosa;\n* Patient with recurrent SCC or SCC at very high risk of relapse defined by one of the following criteria:\n\n * PNI with \\> 2 other risk factors,\n * \\> 3 risk factors,\n * bone invasion,\n * immunosuppression by immunosuppressive treatments (whatever the reason).\n* Patient with SCC with a single risk factor other than PNI;\n* Patient with SCC with lymph node or distant metastasis;\n* Patient with a history of solid cancer undergoing chemotherapy;\n* Patient with a contraindication to radiotherapy;\n* Patient with a history of radiotherapy in the area of the lesion;\n* Participation in another clinical trial that may interfere with the assessment of the primary endpoint;\n* Patient under guardianship or curatorship or deprived of liberty;\n* Pregnant or breastfeeding woman.'}, 'identificationModule': {'nctId': 'NCT06692556', 'acronym': 'SPINO-RT', 'briefTitle': 'Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Randomized Comparative Multicenter Phase III Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence', 'orgStudyIdInfo': {'id': 'SPINO-RT (ET24-046)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adjuvant radiotherapy', 'description': "Radiation therapy should be started within 8 to 10 weeks after surgery.\n\nAn equivalent dose of 45 to 50 Gy will be delivered on the operating bed. The irradiation techniques used may be either external radiation therapy with high-energy photons or electrons or brachytherapy. Patients will be monitored regularly until the date of the first local, regional or metastatic relapse, or until the date of death if they do not relapse.\n\nRegardless of the type of relapse, remedial treatments will be left to the The investigator's discretion; they will be collected in the data collection book as well as data on subsequent relapses, up to the first metastatic relapse.", 'interventionNames': ['Radiation: Adjuvant radiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Surveillance', 'description': 'Patients will not receive any treatment after surgery and will be monitored regularly until the date of their first local, regional or metastatic relapse, or until the date of death if they do not relapse.\n\nRegardless of the type of relapse, the treatment to be used is left to the discretion of the investigator; it will be collected in the data collection book as well as data on subsequent relapses up to the first metastatic relapse.'}], 'interventions': [{'name': 'Adjuvant radiotherapy', 'type': 'RADIATION', 'description': "Patients will receive an adjuvant radiotherapy corresponding to an equivalent dose of 45 to 50 Gy (Equivalent Dose in 2 Gy Fractions \\[EQD2\\] with a tumor alpha/beta ratio of 10 Gy) delivered on the operating bed.\n\nPatients will be treated by :\n\n* either external radiation therapy using high-energy electrons or photons:\n\n * 45 Gy in 15 fractions of 3 Gy\n * 50 Gy in 25 fractions of 2 Gy\n* or interstitial brachytherapy or brachytherapy via skin applicators:\n\n * 36 Gy in 8 fractions of 4.5 Gy\n * 36 Gy in 9 fractions of 4 Gy\n * 40 Gy in 8 fractions of 5 Gy\n\nRadiation therapy should be started within 8 weeks after surgery (or 10 if delayed healing).\n\nPatients will be monitored regularly until the date of the first relapse (local, regional or metastatic), or until the date of death (if no relapse).\n\nRegardless of the type of relapse, remedial treatments will be left to the the investigator's discretion up to the first metastatic relapse.", 'armGroupLabels': ['Adjuvant radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'state': "Côte-d'Or", 'country': 'France', 'contacts': [{'name': 'Gilles TRUC, Dr', 'role': 'CONTACT', 'email': 'gtruc@cgfl.fr', 'phone': '+33 3 80 73 75 18'}, {'name': 'Gilles TRUC, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alice HERVIEU, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '26102', 'city': 'Romans-sur-Isère', 'state': 'Drôme', 'country': 'France', 'contacts': [{'name': 'François SKOWRON, Dr', 'role': 'CONTACT', 'email': 'f.skowron@hopitaux-drome-nord.fr', 'phone': '+33 4 75 05 75 80'}, {'name': 'François SKOWRON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Marc MICHEL, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Romans - Hopitaux Drôme Nord', 'geoPoint': {'lat': 45.0496, 'lon': 5.06602}}, {'zip': '26000', 'city': 'Valence', 'state': 'Drôme', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste GUY, Dr', 'role': 'CONTACT', 'email': 'dr.guy@cmc-valence.org'}, {'name': 'Jean-Baptiste GUY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Julien LANGRAND-ESCURE, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre de Radiothérapie Marie Curie', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '26000', 'city': 'Valence', 'state': 'Drôme', 'country': 'France', 'contacts': [{'name': 'Florent GRANGE, Dr', 'role': 'CONTACT', 'email': 'fgrange@valence.fr', 'phone': '+33 4 75 75 75 49'}, {'name': 'Florent GRANGE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '29200', 'city': 'Brest', 'state': 'Finistère', 'country': 'France', 'contacts': [{'name': 'Vincent BOURBONNE, Dr', 'role': 'CONTACT', 'email': 'vincent.bourbonne@chu-brest.fr', 'phone': '+33 2 98 22 33 98'}, {'name': 'Vincent BOURBONNE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Delphine LEGOUPIL, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '33604', 'city': 'Pessac', 'state': 'Gironde', 'country': 'France', 'contacts': [{'name': 'Nora OUHABRACHE, Dr', 'role': 'CONTACT', 'email': 'nora.ouhabrache@chu-bordeaux.fr', 'phone': '+33 5 57 62 33 12'}, {'name': 'Nora OUHABRACHE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie BEYLOT-BARRY, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Bordeaux', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '74374', 'city': 'Épagny-Metz-Tessy', 'state': 'Haute-Savoie', 'country': 'France', 'contacts': [{'name': 'Julie DE QUATREBARBES, Dr', 'role': 'CONTACT', 'email': 'jdequatrebarbes@ch-annecygenevois.fr', 'phone': '+33 4 50 63 68 63'}, {'name': 'Julie DE QUATREBARBES, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amélie DUTHEIL, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Annecy Genevois'}, {'zip': '35033', 'city': 'Rennes', 'state': 'Ille-et-Vilaine', 'country': 'France', 'contacts': [{'name': 'Monica DINULESCU, Dr', 'role': 'CONTACT', 'email': 'monica.dinulescu@chu-rennes.fr'}, {'name': 'Monica DINULESCU, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '38700', 'city': 'La Tronche', 'state': 'Isère', 'country': 'France', 'contacts': [{'name': 'Sabiha TRABELSI-MESSAI, Dr', 'role': 'CONTACT', 'email': 'strabelsimessai@chu-grenoble.fr', 'phone': '+33 4 76 76 66 16'}, {'name': 'Sabiha TRABELSI-MESSAI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Grenoble-Alpes', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '41016', 'city': 'Blois', 'state': 'Loir-et-Cher', 'country': 'France', 'contacts': [{'name': 'Guido BENS, Dr', 'role': 'CONTACT', 'email': 'bensgui@ch-blois.fr'}, {'name': 'Guido BENS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Simone Veil de Blois', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': '44093', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'contacts': [{'name': 'Gaëlle QUEREUX, Dr', 'role': 'CONTACT', 'email': 'gaelle.quereux@chu-nantes.fr', 'phone': '+33 2 40 08 31 44'}, {'name': 'Gaëlle QUEREUX, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lise BOUSSEMART, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Casandra COLTOIU, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie DAUDE, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fanny GOHARD, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah LE NAOUR, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marie PIROTH, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Nantes - Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '51726', 'city': 'Reims', 'state': 'Marne', 'country': 'France', 'contacts': [{'name': 'Antonio Manuel DA SILVA RIBEIRO MOTA, Dr', 'role': 'CONTACT', 'email': 'antonio.dasilvaribeiromota@reims.unicancer.fr', 'phone': '+33 3 26 50 43 63'}, {'name': 'Antonio Manuel DA SILVA RIBEIRO MOTA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claire CARLIER, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Camille MAZZA, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut Godinot', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'state': 'MMeurthe-et-Moselle', 'country': 'France', 'contacts': [{'name': 'Sophie RENARD, Dr', 'role': 'CONTACT', 'email': 's.renard@nancy.unicancer.fr', 'phone': '+33 3 83 59 86 10'}, {'name': 'Sophie RENARD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Florence GRANEL BROCARD, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '56322', 'city': 'Lorient', 'state': 'Morbihan', 'country': 'France', 'contacts': [{'name': 'Caroline JACOBZONE-LEVEQUE, Dr', 'role': 'CONTACT', 'email': 'c.jacobzoneleveque@ghbs.bzh', 'phone': '+33 6 16 98 31 79'}, {'name': 'Caroline JACOBZONE-LEVEQUE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian SIRE, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claire-Alice DE SALINS, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guillaume BERA, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kévin CHASSAIN, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Groupe Hospitalier Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '42300', 'city': 'Roanne', 'state': 'Pays de la Loire Region', 'country': 'France', 'contacts': [{'name': 'Amel BLANCHARD, Dr', 'role': 'CONTACT', 'email': 'amel.blanchard@ch-roanne.fr', 'phone': '+33 4 77 44 32 77'}, {'name': 'Amel BLANCHARD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Petre LUPU BRATILOVEANU, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre hospitalier de Roanne'}, {'zip': '42271', 'city': 'Saint Priest En Jarez', 'state': 'Pays de la Loire Region', 'country': 'France', 'contacts': [{'name': 'Elodie GUILLAUME, Dr', 'role': 'CONTACT', 'email': 'elodie.guillaume@chu-st-etienne.fr', 'phone': '+33 4 77 91 71 02'}, {'name': 'Elodie GUILLAUME, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Luc PERROT, DrNicolas', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nicolas VIAL, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Saïd SOLTANI, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric JADAUD, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire de Saint-Etienne - Hôpital Nord'}, {'zip': '63033', 'city': 'Clermont-Ferrand', 'state': 'Puy-de-Dôme', 'country': 'France', 'contacts': [{'name': 'Sandrine MANSARD, Dr', 'role': 'CONTACT', 'email': 'smansard@chu-clermontferrand.fr', 'phone': '+33 4 73 75 05 50'}, {'name': 'Sandrine MANSARD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie BACHELERIE, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jacques ROUANET, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': "Michel D'INCAN, Dr", 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '76031', 'city': 'Rouen', 'state': 'Seine-Maritime', 'country': 'France', 'contacts': [{'name': 'Anne-Bénédicte DUVAL-MODESTE, Dr', 'role': 'CONTACT', 'email': 'anne-benedicte.duval-modeste@chu-rouen.fr', 'phone': '+33 2 32 88 81 41'}, {'name': 'Anne-Bénédicte DUVAL-MODESTE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Rouen - Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '80054', 'city': 'Amiens', 'state': 'Somme', 'country': 'France', 'contacts': [{'name': 'Alexandre COUTTE, Dr', 'role': 'CONTACT', 'email': 'coutte.alexandre@chu-amiens.fr', 'phone': '+33 3 22 45 56 40'}, {'name': 'Alexandre COUTTE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Universitaire Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '83800', 'city': 'Toulon', 'state': 'Var', 'country': 'France', 'contacts': [{'name': 'Safia ABED, Dr', 'role': 'CONTACT', 'email': 'abed.safia@gmail.com'}, {'name': 'Safia ABED, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hôpital d'instruction des armées Sainte-Anne", 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Mona AMINI-ADLE, Dr', 'role': 'CONTACT', 'email': 'mona.amini-adle@lyon.unicancer.fr', 'phone': '+33 4 78 78 59 96'}, {'name': 'Mona AMINI-ADLE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adeline PETRE, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75877', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'contacts': [{'name': 'Florence BRUNET-POSSENTI, Dr', 'role': 'CONTACT', 'email': 'florence.brunet-possenti@aphp.fr', 'phone': '+33 6 79 85 46 98'}, {'name': 'Florence BRUNET-POSSENTI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline FAUCON, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra MOKRZYCKI, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Caroline HALIMI LEVY, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diane EVRARD, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Bichat Claude-Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Julien GAUTIER', 'role': 'CONTACT', 'email': 'julien.gautier@lyon.unicancer.fr', 'phone': '+33 4.26.55.68.29'}], 'overallOfficials': [{'name': 'Mona AMINI-ADLE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}