Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04954820
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2021-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447941', 'term': 'lutetium Lu 177 dotatate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'It\'s a prospective, national, multicenter, open-label, randomized, phase II study, to compare 2 additional cycles of Lutathera® versus active surveillance in patients who already received two cycles of "Second PRRT" (already retreated with two cycles).\n\nWritten informed consent will be collected before any study related procedures take place.\n\nPatients previously treated with 4 cycles of Lutathera® will be registered after a first progression (clinic, biologic and/or radiologic) of their neuroendocrine tumor.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the efficacy of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance during 6 months in patients already retreated with two cycles.', 'timeFrame': 'assessement every cycle (every 8 weeks) 6 months from randomization', 'description': 'defined as a change of tumoral assessment (Complete Response, Partial Response and Stable Disease from RECIST v1.1) with an evaluation every 2 months.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Safety', 'timeFrame': 'during 6 months in patients already retreated with two cycles (each cycle is 8 weeks)', 'description': 'Number and type of adverse event according to NCI-CTCAE v5.0.'}, {'measure': 'Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Progression free survival', 'timeFrame': 'the time without progression of disease during 5 years after the treatment,', 'description': 'the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first'}, {'measure': 'Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Overall survival', 'timeFrame': 'the time without death during 5 years after the treatment', 'description': 'the time from randomization until death from any cause.'}, {'measure': 'To assess quality of life of general patient', 'timeFrame': 'during and after treatment in both arm : every 8 wweks during the treatment, every 3 months during 1 year post treatment and every year during 4 years post treatment', 'description': 'Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality-of-life questionnaire C30, no min and max values)'}, {'measure': 'To assess quality of life of gastrointestinal neuroendocrine tumor', 'timeFrame': 'during and after treatment in both arm : every 8 wweks during the treatment, every 3 months during 1 year post treatment and every year during 4 years post treatment', 'description': 'Quality of life will be measured by EORTC GI.NET21 questionnaire (European Organisation for Research and Treatment of Cancer, gastrointestinal neuroendocrine tumor, no min and max values)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuroendocrine Tumors', 'Intestinal Well Differentiated Endocrine Tumor', 'Progressive Disease']}, 'referencesModule': {'references': [{'pmid': '18565894', 'type': 'BACKGROUND', 'citation': 'Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377.'}, {'pmid': '28076709', 'type': 'BACKGROUND', 'citation': "Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427."}, {'pmid': '29878866', 'type': 'BACKGROUND', 'citation': 'Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.'}, {'pmid': '31395036', 'type': 'BACKGROUND', 'citation': 'Rudisile S, Gosewisch A, Wenter V, Unterrainer M, Boning G, Gildehaus FJ, Fendler WP, Auernhammer CJ, Spitzweg C, Bartenstein P, Todica A, Ilhan H. Salvage PRRT with 177Lu-DOTA-octreotate in extensively pretreated patients with metastatic neuroendocrine tumor (NET): dosimetry, toxicity, efficacy, and survival. BMC Cancer. 2019 Aug 8;19(1):788. doi: 10.1186/s12885-019-6000-y.'}, {'pmid': '29513039', 'type': 'BACKGROUND', 'citation': 'Vaughan E, Machta J, Walker M, Toumpanakis C, Caplin M, Navalkissoor S. Retreatment with peptide receptor radionuclide therapy in patients with progressing neuroendocrine tumours: efficacy and prognostic factors for response. Br J Radiol. 2018 Nov;91(1091):20180041. doi: 10.1259/bjr.20180041. Epub 2018 Mar 20.'}, {'pmid': '28246882', 'type': 'BACKGROUND', 'citation': 'Yordanova A, Mayer K, Brossart P, Gonzalez-Carmona MA, Strassburg CP, Essler M, Ahmadzadehfar H. Safety of multiple repeated cycles of 177Lu-octreotate in patients with recurrent neuroendocrine tumour. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1207-1214. doi: 10.1007/s00259-017-3652-1. Epub 2017 Mar 1.'}, {'pmid': '24030668', 'type': 'BACKGROUND', 'citation': 'Sabet A, Haslerud T, Pape UF, Sabet A, Ahmadzadehfar H, Grunwald F, Guhlke S, Biersack HJ, Ezziddin S. Outcome and toxicity of salvage therapy with 177Lu-octreotate in patients with metastatic gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2014 Feb;41(2):205-10. doi: 10.1007/s00259-013-2547-z. Epub 2013 Sep 13.'}, {'pmid': '20150247', 'type': 'BACKGROUND', 'citation': 'van Essen M, Krenning EP, Kam BL, de Herder WW, Feelders RA, Kwekkeboom DJ. Salvage therapy with (177)Lu-octreotate in patients with bronchial and gastroenteropancreatic neuroendocrine tumors. J Nucl Med. 2010 Mar;51(3):383-90. doi: 10.2967/jnumed.109.068957. Epub 2010 Feb 11.'}, {'pmid': '25999429', 'type': 'BACKGROUND', 'citation': 'Gleisner KS, Brolin G, Sundlov A, Mjekiqi E, Ostlund K, Tennvall J, Larsson E. Long-Term Retention of 177Lu/177mLu-DOTATATE in Patients Investigated by gamma-Spectrometry and gamma-Camera Imaging. J Nucl Med. 2015 Jul;56(7):976-84. doi: 10.2967/jnumed.115.155390. Epub 2015 May 21.'}, {'pmid': '28331954', 'type': 'BACKGROUND', 'citation': 'Sundlov A, Sjogreen-Gleisner K, Svensson J, Ljungberg M, Olsson T, Bernhardt P, Tennvall J. Individualised 177Lu-DOTATATE treatment of neuroendocrine tumours based on kidney dosimetry. Eur J Nucl Med Mol Imaging. 2017 Aug;44(9):1480-1489. doi: 10.1007/s00259-017-3678-4. Epub 2017 Mar 22.'}, {'pmid': '30506283', 'type': 'BACKGROUND', 'citation': 'Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized 177Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.'}, {'pmid': '36550428', 'type': 'DERIVED', 'citation': 'Deshayes E, Assenat E, Meignant L, Bardies M, Santoro L, Gourgou S. A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera(R) in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH). BMC Cancer. 2022 Dec 22;22(1):1346. doi: 10.1186/s12885-022-10443-4.'}], 'seeAlsoLinks': [{'url': 'https://www.ema.europa.eu/en/documents/product-information/lutathera-epar-product-information_fr.pdf', 'label': 'RCP'}, {'url': 'https://www.has-sante.fr/jcms/pprd_2983166/fr/lutathera-lutecium-177lu-oxodotreotide', 'label': 'HAS'}]}, 'descriptionModule': {'briefSummary': 'In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.', 'detailedDescription': 'The NETTER-1 clinical trial compared peptide receptor radionuclide therapy (PRRT) with \\[177Lu\\]Lu-DOTA-TATE (Lutathera®) every eight weeks (4 doses) plus 30 mg octreotide LAR every 4 weeks with high dose (60 mg) of octreotide LAR every 4 weeks in patients with progressive and unresectable midgut neuroendocrine well differentiated (G1, G2) tumors (NETs) with somatostatin-receptor positive imaging (SSTRi+). Lutathera® improves both median progression free survival (PFS) (28.4 months vs 8.5 months) and median overall survival (OS) ("not reached" vs 27.4 months) with a follow-up of 42 months. Lutathera® also has an impact on quality of life. Therefore, this treatment was approved by the European Medicines Agency and is now reimbursed in France in that specific indication. Despite these promising results, progression will occur in most of patients within a variable time with limited treatment options left. Retreatment with additional cycles of Lutathera® may be an option. Van der Zwan et al. showed in a large retrospective cohort (the "ROTTERDAM cohort") a median PFS of 14.6 months after retreatment with two additional cycles of PRRT with \\[177Lu\\]Lu-DOTA-TATE and a significant longer OS than in the non-randomized control group. Interestingly, the safety was similar in salvage group than in initial PRRT: no grade (G) 3/4 renal toxicity occurred and hematological toxicities were similar to the group of patients who received the initial treatment (4 cycles). In a smaller cohort of 15 patients, Yordanova et al. showed that 8 or more cycles of \\[177Lu\\]Lu-DOTA-TATE were well tolerated and led to a survival improvement. In this study, each salvage therapy consisted of 2 or 3 cycles. No severe (G3, G4) renal toxicity or G4 adverse event occurred. In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years,\n* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),\n* Patient previously treated with 4 cycles of Lutathera® (defined as "First PRRT"),\n* Disease control after "First PRRT" ≥ 12 months,\n* Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT,\n* Decision of retreatment with Lutathera® (defined as "Second PRRT") validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process,\n* ECOG performance status 0-2,\n* Life expectancy ≥ 6 months as prognosticated by the physician,\n* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (\\>= liver of surrounding tissue),\n* Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,\n* Adequate bone marrow reserve (Hb \\> 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³),\n* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),\n* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,\n* Patient´s signed written informed consent,\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\n* Affiliation to the French Social Security System\n\nExclusion Criteria:\n\n* Patient who did not respond (no CR, PR or SD) to "first PRRT".\n* Radiological progression after two cycles of "Second PRRT" according to RECIST version 1.1,\n* Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,\n* Pancreatic NET,\n* NeuroEndocrine Carcinoma,\n* Prior external beam radiation therapy to more than 25% of the bone marrow,\n* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) \\< 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \\> 2.5 x ULN or ALT/AST \\> 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin \\> 2.5 x ULN),\n* Serum albumin \\< 3.0 g/dL unless prothrombin time is within the normal range,\n* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,\n* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,\n* Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy)\n* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),\n* Pregnancy or breast feeding,\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient\'s participation in the study or evaluation of the study results,\n* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,\n* Concomitant participation or participation within the last 30 days in another clinical trial,\n* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.\n* Legal incapacity or physical, psychological or mental status interfering with the patient\'s ability to sign the informed consent or to terminate the study.'}, 'identificationModule': {'nctId': 'NCT04954820', 'acronym': 'ReLUTH', 'briefTitle': 'Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor', 'orgStudyIdInfo': {'id': 'PROICM 2021-04 REL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': '2 additional infusions of Lutathera® according to the marketing authorization schema', 'interventionNames': ['Drug: Lutathera']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'No treatment with active monitoring (clinical, biological and radiological follow-up) every 2 months.'}], 'interventions': [{'name': 'Lutathera', 'type': 'DRUG', 'description': '2 additional infusions of Lutathera®', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvie GIRAUD, MD', 'role': 'CONTACT', 'email': 'sylvie.girault@ico.unicancer.fr'}], 'facility': "Institut de Cancérologie de l'Ouest Site d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Paul SCHWARTZ, MD', 'role': 'CONTACT', 'email': 'p.schwartz@bordeaux.unicancer.fr'}], 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Phillipe METGES, MD', 'role': 'CONTACT', 'email': 'jean-philippe.metges@chu-brest.fr'}], 'facility': 'CHRU Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Solène CASTELLNOU, MD', 'role': 'CONTACT', 'email': 'solene.castellnou@chu-lyon.fr'}], 'facility': 'Hospices civils de LYON - GHE', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '14076', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elisabeth QAUK, MD', 'role': 'CONTACT', 'email': 'e.quak@baclesse.unicancer.fr'}], 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '73011', 'city': 'Chambéry', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Cyril BOURRE, MD', 'role': 'CONTACT', 'email': 'jeancyril.bourre@ch-metropole-savoie.fr'}], 'facility': 'CH Métropole de Savoie', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '63011', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anthony KELLY, MD', 'role': 'CONTACT', 'email': 'Antony.KELLY@clermont.unicancer.fr'}], 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Louis DE MESTIER, MD', 'role': 'CONTACT', 'email': 'louis.demestier@aphp.fr'}], 'facility': 'Hopital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '21079', 'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Côme LEPAGE, MD', 'role': 'CONTACT', 'email': 'come.lepage@u-bourgogne.fr'}], 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie ROUX, MD', 'role': 'CONTACT', 'email': 'jroux@chu-grenoble.fr'}], 'facility': 'CHU Grenoble Alpes (CHUGA)', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '59000', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amandine BERON, PR', 'role': 'CONTACT', 'email': 'Amandine.beron@chru-lille.fr'}], 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69008', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Laure GIRAUDET, MD', 'role': 'CONTACT', 'email': 'anneLaure.giraudet@lyon.unicancer.fr'}], 'facility': 'Centre léon bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13009', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie CHARRIER, MD', 'role': 'CONTACT', 'email': 'charriern@ipc.unicancer.fr'}], 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David TAIEB, PR', 'role': 'CONTACT', 'email': 'david.taieb@ap-hm.fr'}], 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel DESHAYES, MD', 'role': 'CONTACT', 'email': 'emmanuel.deshayes@icm.unicancer.fr'}], 'facility': "ICM Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine ANSQUER, MD', 'role': 'CONTACT', 'email': 'catherine.ansquer@chu-nantes.fr'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06189', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Danielle BENISVY, MD', 'role': 'CONTACT', 'email': 'danielle.benisvy@nice.unicancer.fr'}], 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlotte LUSSEY, MD', 'role': 'CONTACT', 'email': 'charlotte.lussey@aphp.fr'}], 'facility': 'Hôpital Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence TENENBAUM, MD', 'role': 'CONTACT', 'email': 'florence.tenenbaum@aphp.fr'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ghoufrane TLILI, MD', 'role': 'CONTACT', 'email': 'ghoufrane.tlili@chu-bordeaux.fr'}], 'facility': 'Hôpital Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David TONNELET, MD', 'role': 'CONTACT', 'email': 'david.tonnelet@chb.unicancer.fr'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '76031', 'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric Di FIORE, MD', 'role': 'CONTACT', 'email': 'frederic.difiore@chu-rouen.fr'}], 'facility': 'CHU de Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent HABOUZIT, MD', 'role': 'CONTACT', 'email': 'vincent.habouzit@chu-st-etienne.fr'}], 'facility': 'CHU ST Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '44805', 'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hélène SENELLART, MD', 'role': 'CONTACT', 'email': 'helene.senellart@ico.unicancer.fr'}], 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67033', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alessio IMPERIALE, PhD', 'role': 'CONTACT', 'email': 'a.imperiale@icans.eu'}], 'facility': 'Institut de cancérologie Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31100', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lawrence DIERICKX, MD', 'role': 'CONTACT', 'email': 'dierickx.lawrence@iuct-oncopole.fr'}], 'facility': 'IUCT Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elodie CHEVALIER, MD', 'role': 'CONTACT', 'email': 'e.chevalier@chru-nancy.fr'}], 'facility': 'CHRU Nancy Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric BAUDIN, MD', 'role': 'CONTACT', 'email': 'eric.baudin@gustaveroussy.fr'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Moussion Aurore, MD', 'role': 'CONTACT', 'email': 'aurore.moussion@icm.unicancer.fr', 'phone': '+33467612446', 'phoneExt': '+33'}, {'name': 'Texier Emmanuelle', 'role': 'CONTACT', 'email': 'emmanuelle.texier@icm.unicancer.fr', 'phone': '0467613102'}], 'overallOfficials': [{'name': 'Deshayes Emmanuel, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'ICM Co. Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients All participant data collected during the trial, after coding by an inclusion number, 1st letter of the surname and first name can be shared.\n\nParticipant data will be available upon request and with the completion of a contract between the sponsor and the applicant.\n\nThe study protocol, the statistical analysis plan and the analytical code may also be subject to data sharing under a transfer contract (EU-MCR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}