Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-27 @ 11:31 AM
Study NCT ID:
NCT06052332
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2023-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2033-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'At 3 years after randomisation', 'description': 'Overall survival (OS) will be calculated from randomisation to death from any cause.'}, {'measure': 'Progression-free survival', 'timeFrame': 'At 3 years after randomisation', 'description': 'Progression-free survival (PFS) will be calculated from randomisation to any of the following events: unresectable tumour due to local tumour progression, R2 resection of the primary tumour, loco-regional recurrence after an R0/R1 resection, distant metastases, or death from any cause.'}, {'measure': 'Any grade peripheral sensory neuropathy', 'timeFrame': 'At 3 years after randomisation', 'description': 'Any grade peripheral sensory neuropathy as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.'}, {'measure': 'Grade ≥3 toxicities during treatment', 'timeFrame': 'At 3 years after randomisation', 'description': 'Grade ≥3 toxicities during treatment (i.e., from the 1st day of treatment until the EOT visit) as assessed by the investigator according to the NCI-CTCAE v5.0 will be analysed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rectal cancer'], 'conditions': ['Locally Advanced Rectal Cancer', 'Older People']}, 'descriptionModule': {'briefSummary': 'The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.', 'detailedDescription': 'The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.\n\nSubjects meeting all eligibility criteria will be randomised in a 1:1 ratio to either the conventional arm or the TNT arm (The study design is shown in figure 3.1 and 3.2).\n\nConventional arm consists of:\n\n* SCRT (5 fractions of 5 Gy), followed by\n* Surgery (according to the principles of TME) or watch \\& wait, followed by\n* Optional adjuvant chemotherapy OR\n* LCCRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by\n* Surgery (according to the principles of TME) or watch \\& wait, followed by\n* Optional adjuvant chemotherapy\n\nTNT arm Different treatment regimens can be used in the TNT arm including Rapido, Rapido light, OPRA INCT-CRT or OPRA CRT-CNCT. The regimen to use will be decided by the investigator and will need to be declared before randomisation. No switch between regimens is allowed during the study treatment period.\n\nThe Rapido regimen consists of:\n\n* SCRT (5 fractions of 5 Gy), followed by\n* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by\n* Surgery (according to the principle of TME) or "watch \\& wait".\n\nThe Rapido light regimen consists of:\n\n* SCRT (5 fractions of 5 Gy), followed by\n* Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX), followed by\n* Surgery (according to the principle of TME) or "watch \\& wait".\n\nThe OPRA with induction chemotherapy (INCT-CRT) regimen, consists of:\n\n* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by\n* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by\n* Surgery (according to the principle of TME) or "watch \\& wait"\n\nThe OPRA with consolidation chemotherapy (CRT-CNCT) regimen consists of:\n\n* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by\n* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by\n* Surgery (according to the principle of TME) or "watch \\& wait".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 70 years old\n2. ECOG performance status (PS):\n\n * ≤1 if age \\> 75 years old\n * ≤2 if age ≤ 75 years old\n3. Histologically or cytologically confirmed adenocarcinoma of the rectum\n4. Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge\n5. Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement/threatening \\[i.e.,tumour within 1 mm of the MRF\\], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible.\n6. Adequate bone marrow function as defined below:\n\n * Absolute neutrophil count ≥1,500/µL\n * Haemoglobin ≥9 g/dL\n * Platelets ≥100,000/µL\n7. Adequate liver function as defined below:\n\n * Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome \\<3xUNL is allowed\n * AST (SGOT) and ALT (SGPT) ≤2.5 x ULN\n * Alkaline phosphatase ≤2.5 x ULN\n8. Adequate renal function as defined by estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73m² (according to the CKD-EPI 2021 equation).\n9. Absence of clinical conditions that in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery.\n10. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n11. Male subjects with partners of childbearing potential must agree to use condom during the course of this study and for at least 6 months after the last administration of study drugs.\n\nExclusion Criteria:\n\n1. Extensive growth into cranial part of the sacrum (above S2/3 junction) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is achieved.\n2. Presence of metastatic disease or recurrent rectal tumour.\n3. Presence of grade ≥2 peripheral neuropathy according to the Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0.\n4. Significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n5. Any contraindication to pelvic irradiation as evaluated by the investigator.\n6. Known hypersensitivity reactions to the study drugs or to any excipients, premedications or non-investigational medicinal products or concomitant medications.\n7. Any investigational anti-cancer therapy other than the protocol specified therapies (participation in other prospective studies which do not imply any specific intervention may be allowed after discussion with the Study Chair).\n8. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment.\n9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (grade III or IV as classified by the New York Heart Association), or serious cardiac arrhythmia requiring medication within the past 6 months.\n10. Complete dihydropyrimidine dehydrogenase (DPD) deficiency.\n11. Any previous treatment for rectal cancer.\n12. Use of brivudine, sorivudine or their chemically related analogues."}, 'identificationModule': {'nctId': 'NCT06052332', 'acronym': 'SHAPERS', 'briefTitle': 'Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jules Bordet Institute'}, 'officialTitle': 'Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer: a Multicentre, Open-label, Randomised Pragmatic Clinical Trial', 'orgStudyIdInfo': {'id': 'IJB-SHAPERS-ODN-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional arm', 'description': '* SCRT (5 fractions of 5 Gy)\n* Surgery (according to the principle of TME) or watch \\& wait\n* Optional adjuvant chemotherapy\n\nOR\n\n* LCCRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by\n* Surgery (according to the principles of TME) or watch \\& wait, followed by\n* Optional adjuvant chemotherapy', 'interventionNames': ['Radiation: Short course radiotherapy', 'Drug: Adjuvant chemotherapy (optional)', 'Procedure: Total mesorectal excision', 'Radiation: Long course chemoradiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TNT arm', 'description': 'Rapido regimen:\n\n* SCRT (5 fractions of 5 Gy)\n* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)\n* Surgery (according to the principle of TME) or "watch \\& wait"\n\nOr\n\nRapido light regimen:\n\n* SCRT\n* Up to 12 weeks of oxaliplatin based chemotherapy\n* Surgery or "watch \\& wait"\n\nOr\n\nOPRA with induction chemotherapy (INCT-CRT) regimen:\n\n* Up to 16 weeks of oxaliplatin-based chemotherapy\n* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine)\n* Surgery or "watch \\& wait"\n\nOr\n\nOPRA with consolidation chemotherapy (CRT-CNCT) regimen:\n\n* CRT\n* Up to 16 weeks of oxaliplatin-based chemotherapy\n* Surgery or "watch \\& wait"', 'interventionNames': ['Procedure: Total mesorectal excision', 'Combination Product: Total neoadjuvant therapy']}], 'interventions': [{'name': 'Short course radiotherapy', 'type': 'RADIATION', 'description': 'Patients will receive 5 daily fractions of radiotherapy. Each fraction will consist of 5 Gy for a total dose of 25 Gy.', 'armGroupLabels': ['Conventional arm']}, {'name': 'Adjuvant chemotherapy (optional)', 'type': 'DRUG', 'description': "The choice of the adjuvant chemotherapy is to the investigator's discretion.", 'armGroupLabels': ['Conventional arm']}, {'name': 'Total mesorectal excision', 'type': 'PROCEDURE', 'description': 'Surgery must be performed according to the principles of total mesorectal excision. A "watch \\& wait" approach is allowed for those subjects who have clinical complete response according to the local assessment.', 'armGroupLabels': ['Conventional arm', 'TNT arm']}, {'name': 'Total neoadjuvant therapy', 'type': 'COMBINATION_PRODUCT', 'description': "The choice of the TNT is left to the investigator's discretion.\n\nIf RAPIDO:\n\n* SCRT (5 fractions of 5 Gy), followed by\n* Up to 18 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)\n\nIf RAPIDO light:\n\n* SCRT (5 fractions of 5 Gy), followed by\n* Up to 12 weeks of oxaliplatin based chemotherapy (mFOLFOX6 or CAPOX)\n\nIf OPRA with induction chemotherapy:\n\n* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX), followed by\n* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine)\n\nIf OPRA with consolidation chemotherapy:\n\n* CRT (25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine) followed by\n* Up to 16 weeks of oxaliplatin-based chemotherapy (mFOLFOX6 or CAPOX)", 'armGroupLabels': ['TNT arm']}, {'name': 'Long course chemoradiotherapy', 'type': 'RADIATION', 'description': 'Patients will receive 25-28 fractions of 1.8-2.0 Gy each +/- a boost to the primary tumour and involved lymph nodes, for a total of 50-56 Gy of radiation combined with either continuous infusion fluorouracil or capecitabine', 'armGroupLabels': ['Conventional arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Antwerp', 'state': 'Antwerpen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Ines Joye, MD', 'role': 'CONTACT', 'email': 'ines.joye@gza.be'}, {'name': 'Ines Joye, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ZAS Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerpen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Timon Vandamme, MD', 'role': 'CONTACT', 'email': 'oncotrials@uza.be'}, {'name': 'Timon Vandamme, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZA Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '2300', 'city': 'Turnhout', 'state': 'Antwerpen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Leen Mortier, MD', 'role': 'CONTACT', 'email': 'leen.mortier@azturnout.be'}, {'name': 'Leen Mortier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Turnhout', 'geoPoint': {'lat': 51.32254, 'lon': 4.94471}}, {'zip': '1070', 'city': 'Anderlecht', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Rita Institut Jules Bordet, MD', 'role': 'CONTACT', 'email': 'rita.saudeconde@hubruxelles.be'}, {'name': 'Rita Saude Conde, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '1160', 'city': 'Auderghem', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Francesco Puleo, MD', 'role': 'CONTACT', 'email': 'francesco_puleo@hotmail.com'}, {'name': 'Francesco Puleo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chirec Delta', 'geoPoint': {'lat': 50.81667, 'lon': 4.43333}}, {'zip': '1000', 'city': 'Brussels', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Amelie Deleporte, MD', 'role': 'CONTACT', 'email': 'amelie.deleporte@stpierre-bru.be'}, {'name': 'Amelie Deleporte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1020', 'city': 'Brussels', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sylvie Lecomte, MD', 'role': 'CONTACT', 'email': 'sylvie.lecomte@chu-brugmann.be'}, {'name': 'Sylvie Lecomte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'state': 'East Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Karen Geboes, MD', 'role': 'CONTACT', 'email': 'karen.geboes@uzgent.be'}, {'name': 'Karen Geboes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9100', 'city': 'Sint-Niklaas', 'state': 'East Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Willem Lybaert, MD', 'role': 'CONTACT', 'email': 'willem.lybaert@telenet.be'}, {'name': 'Willem Lybaert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Nikolaas', 'geoPoint': {'lat': 51.16509, 'lon': 4.1437}}, {'zip': '7100', 'city': 'Haine-Saint-Paul', 'state': 'Hainaut', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Alexandre Dermine, MD', 'role': 'CONTACT', 'email': 'Alexandre.DERMINE@jolimont.be'}, {'name': 'Alexandre Dermine, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de Jolimont', 'geoPoint': {'lat': 50.45544, 'lon': 4.1885}}, {'zip': '7301', 'city': 'Hornu', 'state': 'Hainaut', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sandra Mupingu, MD', 'role': 'CONTACT', 'email': 'sandra.mupingumwanawa@epicura.be'}, {'name': 'Sandra Mupingu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Epicura', 'geoPoint': {'lat': 50.4328, 'lon': 3.82736}}, {'zip': '7000', 'city': 'Mons', 'state': 'Hainaut', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marie Diaz, MD', 'role': 'CONTACT', 'email': 'marie.diaz@helora.be'}, {'name': 'Marie Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Ambroise Pare', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Elodie Gonne, MD', 'role': 'CONTACT', 'email': 'egonne@chuliege.be'}, {'name': 'Elodie GONNE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Liège - Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '6800', 'city': 'Libramont', 'state': 'Luxemburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Frederic Forget, MD', 'role': 'CONTACT', 'email': 'frederic.forget@vivalia.be'}, {'name': 'Frederic Forget, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHA Libramont', 'geoPoint': {'lat': 49.91741, 'lon': 5.37318}}, {'zip': '6000', 'city': 'Charleroi', 'state': 'Namur', 'status': 'SUSPENDED', 'country': 'Belgium', 'facility': 'Grand Hôpital De Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '6042', 'city': 'Charleroi', 'state': 'Namur', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Angélique Covas, MD', 'role': 'CONTACT', 'email': 'angelique.covas@humani.be'}, {'name': 'Angélique Covas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '5530', 'city': 'Godinne', 'state': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laurence FAUGERAS, MD', 'role': 'CONTACT', 'email': 'laurence.faugeras@chuuclnamur.uclouvain.be'}, {'name': 'Laurence FAUGERAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU UCL Namur', 'geoPoint': {'lat': 50.34809, 'lon': 4.87364}}, {'zip': '5000', 'city': 'Namur', 'state': 'Namur', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Yeter Gokburun, MD', 'role': 'CONTACT', 'email': 'yeter.gokburun@chrsm.be'}, {'name': 'Yeter Gokburun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHR Sambre et Meuse (site Meuse)', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '5000', 'city': 'Namur', 'state': 'Namur', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Donatienne Taylor, MD', 'role': 'CONTACT', 'email': 'donatienne.taylor@chuuclnamur.uclouvain.be'}, {'name': 'Donatienne Taylor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU St Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}], 'centralContacts': [{'name': 'Sophie Lepannetier, phD', 'role': 'CONTACT', 'email': 'ctsu.shapers@hubruxelles.be', 'phone': '+32 (0)2 541 34 56'}, {'name': 'Ikram El Idrissi', 'role': 'CONTACT', 'email': 'ctsu.shapers@hubruxelles.be', 'phone': '+32 (0)2 541 30 81'}], 'overallOfficials': [{'name': 'Francesco Sclafani', 'role': 'STUDY_CHAIR', 'affiliation': 'Jules Bordet Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jules Bordet Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}