Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-01 @ 10:10 AM
Study NCT ID:
NCT02008656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2013-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management
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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 358}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease-free survival (DFS)', 'timeFrame': '3 years', 'description': '3-year DFS will be defined as the percentage of patients alive without recurrence of disease at 3 years measured from the date of randomization'}], 'secondaryOutcomes': [{'measure': 'major adverse events', 'timeFrame': '3 years', 'description': 'Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.'}]}, 'conditionsModule': {'keywords': ['CAPECITABINE (ORAL)', 'FLUOROURACIL', 'LEUCOVORIN', 'OXALIPLATIN', 'Total mesorectal excision', 'Chemoradiation therapy', 'Total neoadjuvant therapy', '13-213'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '41381715', 'type': 'DERIVED', 'citation': 'Manca P, Chen CT, Shah F, Lee C, Domenico D, Omer D, Gonzalez S, De Bruijn I, Ahuno S, Chatila WK, Darmofal M, Tavassoly I, Widman AJ, Berger MF, Loomis B, Papaemmanuil E, Yaeger R, Zviran A, Garcia-Aguilar J, Sanchez-Vega F. Ultrasensitive ctDNA monitoring for organ preservation in patients with locally advanced rectal cancer. NPJ Precis Oncol. 2025 Dec 11. doi: 10.1038/s41698-025-01208-w. Online ahead of print.'}, {'pmid': '39225603', 'type': 'DERIVED', 'citation': 'Williams H, Omer DM, Thompson HM, Lin ST, Verheij FS, Miranda J, Yuval JB, Buckley J, Marco MR, Qin LX, Dombroski DA, Kedar R, Oto A, Korngold E, Veniero JC, Gandhi S, Krishnaraj A, Jagtiani M, Ohanian K, Vu D, Hope TA, Lee S, Wasnik AP, Madhuripan N, Gollub MJ, Garcia-Aguilar J; OPRA Consortium. MRI Predicts Residual Disease and Outcomes in Watch-and-Wait Patients with Rectal Cancer. Radiology. 2024 Sep;312(3):e232748. doi: 10.1148/radiol.232748.'}, {'pmid': '38194231', 'type': 'DERIVED', 'citation': 'Thompson HM, Omer DM, Lin S, Kim JK, Yuval JB, Verheij FS, Qin LX, Gollub MJ, Wu AJ, Lee M, Patil S, Hezel AF, Marcet JE, Cataldo PA, Polite BN, Herzig DO, Liska D, Oommen S, Friel CM, Ternent CA, Coveler AL, Hunt SR, Garcia-Aguilar J; OPRA Consortium. Organ Preservation and Survival by Clinical Response Grade in Patients With Rectal Cancer Treated With Total Neoadjuvant Therapy: A Secondary Analysis of the OPRA Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350903. doi: 10.1001/jamanetworkopen.2023.50903.'}, {'pmid': '37883738', 'type': 'DERIVED', 'citation': 'Verheij FS, Omer DM, Williams H, Lin ST, Qin LX, Buckley JT, Thompson HM, Yuval JB, Kim JK, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Guillem JG, Temple L, Goodman KA, Segal NH, Cercek A, Yaeger R, Nash GM, Widmar M, Wei IH, Pappou EP, Weiser MR, Paty PB, Smith JJ, Wu AJ, Gollub MJ, Saltz LB, Garcia-Aguilar J. Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial. J Clin Oncol. 2024 Feb 10;42(5):500-506. doi: 10.1200/JCO.23.01208. Epub 2023 Oct 26.'}, {'pmid': '35483010', 'type': 'DERIVED', 'citation': 'Garcia-Aguilar J, Patil S, Gollub MJ, Kim JK, Yuval JB, Thompson HM, Verheij FS, Omer DM, Lee M, Dunne RF, Marcet J, Cataldo P, Polite B, Herzig DO, Liska D, Oommen S, Friel CM, Ternent C, Coveler AL, Hunt S, Gregory A, Varma MG, Bello BL, Carmichael JC, Krauss J, Gleisner A, Paty PB, Weiser MR, Nash GM, Pappou E, Guillem JG, Temple L, Wei IH, Widmar M, Lin S, Segal NH, Cercek A, Yaeger R, Smith JJ, Goodman KA, Wu AJ, Saltz LB. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy. J Clin Oncol. 2022 Aug 10;40(23):2546-2556. doi: 10.1200/JCO.22.00032. Epub 2022 Apr 28.'}, {'pmid': '33052753', 'type': 'DERIVED', 'citation': 'Shi DD, Mamon HJ. Playing With Dynamite? A Cautious Assessment of TNT. J Clin Oncol. 2021 Jan 10;39(2):103-106. doi: 10.1200/JCO.20.02199. Epub 2020 Oct 14. No abstract available.'}, {'pmid': '26497495', 'type': 'DERIVED', 'citation': 'Smith JJ, Chow OS, Gollub MJ, Nash GM, Temple LK, Weiser MR, Guillem JG, Paty PB, Avila K, Garcia-Aguilar J; Rectal Cancer Consortium. Organ Preservation in Rectal Adenocarcinoma: a phase II randomized controlled trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or nonoperative management. BMC Cancer. 2015 Oct 23;15:767. doi: 10.1186/s12885-015-1632-z.'}, {'pmid': '26187751', 'type': 'DERIVED', 'citation': 'Garcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Consortium. Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):957-66. doi: 10.1016/S1470-2045(15)00004-2. Epub 2015 Jul 14.'}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to test the hypothesis that patients with Locally advanced rectal cancer ( LARC) treated with Total neoadjuvant therapy (TNT) and Total mesorectal excision (TME) or Non-operative management (NOM) will have an improved 3-year disease-free survival (DFS) compared to patients with similar tumors treated with Chemoradiation therapy (CRT), Total mesorectal excision (TME) and Adjuvant chemotherapy (ACT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically confirmed diagnosis of adenocarcinoma of the rectum\n* Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on MRI\n* Rectal tumor at baseline which would be considered to require complete TME\n* No evidence of distant metastases\n* No prior pelvic radiation therapy\n* No prior chemotherapy or surgery for rectal cancer\n* Age ≥ 18 years The minimum legal age of consent for select Canadian provinces is 19\n* No active infections requiring systemic antibiotic treatment (oral antibiotics are acceptable at the discretion of the treating physician)\n* ECOG Performance status 0-2\n* Women with childbearing potential (WOCBP) who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. A woman of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should be used from trial screening and must be continued throughout the study.\n* Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Patients who do not read or understand English are eligible and may be consented according to institutional and federal regulations.\n* ANC \\> 1.5 cells/mm3, HGB \\> 8.0 gm/dl, PLT \\> 150,000/mm3 total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN.\n\nExclusion Criteria:\n\n* Recurrent rectal cancer\n* Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en block resection will not achieve negative margins.\n* Creatinine level greater than 1.5 times the upper limit of normal.\n* Patients who have received prior pelvic radiotherapy.\n* Patients who are unable to undergo an MRI.\n* Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.\n* Patients with a history of venous thrombotic episodes such as deep venous thrombosis, pulmonary embolus occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Similarly, patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy.\n* Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy for the entire study period.\n* Women who are pregnant or breast-feeding.\n* Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.\n* Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer."}, 'identificationModule': {'nctId': 'NCT02008656', 'briefTitle': 'Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Multicenter Randomized Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management', 'orgStudyIdInfo': {'id': '13-213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INCT', 'description': 'Arm 1 will receive chemotherapy before chemoradiation. This is called induction neoadjuvant chemotherapy arm (INCT). The neoadjuvant chemotherapy regimen is prescribed specifically as 8 cycles of FOLFOX or 5 cycles of CapeOX over a period of approximately 15-16 weeks. Endoscopic exam (2-4 wks) after chemotherapy. If stable or response then pt will have radiation with either 5-FU or capecitabine.', 'interventionNames': ['Drug: Oxaliplatin (OXAL)', 'Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin', 'Drug: Capecitabine (Xeloda®)', 'Radiation: intensity modulated radiotherapy (IMRT)', 'Behavioral: Quality of Life Questionnaires', 'Procedure: DRE-Endoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'CNCT', 'description': 'Arm 2 will receive chemoradiation before chemotherapy This is called the consolidation neoadjuvant chemotherapy arm (CNCT). Pt will have 6 weeks of chemoradiation therapy. Along with the radiation the pt will receive either 5-FU or capecitabine. 2-4 weeks after pt will have endoscopic exam and if stable or response pt will have will have 8 cycles of FOLFOX or 6 cycles of CapeOX.', 'interventionNames': ['Drug: Oxaliplatin (OXAL)', 'Drug: 5-Fluorouracil (5-FU)', 'Drug: Leucovorin', 'Drug: Capecitabine (Xeloda®)', 'Radiation: intensity modulated radiotherapy (IMRT)', 'Behavioral: Quality of Life Questionnaires', 'Procedure: DRE-Endoscopy']}], 'interventions': [{'name': 'Oxaliplatin (OXAL)', 'type': 'DRUG', 'armGroupLabels': ['CNCT', 'INCT']}, {'name': '5-Fluorouracil (5-FU)', 'type': 'DRUG', 'armGroupLabels': ['CNCT', 'INCT']}, {'name': 'Leucovorin', 'type': 'DRUG', 'armGroupLabels': ['CNCT', 'INCT']}, {'name': 'Capecitabine (Xeloda®)', 'type': 'DRUG', 'armGroupLabels': ['CNCT', 'INCT']}, {'name': 'intensity modulated radiotherapy (IMRT)', 'type': 'RADIATION', 'armGroupLabels': ['CNCT', 'INCT']}, {'name': 'Quality of Life Questionnaires', 'type': 'BEHAVIORAL', 'armGroupLabels': ['CNCT', 'INCT']}, {'name': 'DRE-Endoscopy', 'type': 'PROCEDURE', 'armGroupLabels': ['CNCT', 'INCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92868-3849', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'John Muir Health', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48168', 'city': 'Northville', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.43115, 'lon': -83.48327}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'CHI Heath Bergan Mercy', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Colon and Rectal Surgery, Incorporated', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10591', 'city': 'Sleepy Hollow', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center at Phelps', 'geoPoint': {'lat': 41.08565, 'lon': -73.85847}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington School of Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Julio Garcia Aguilar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Colon and Rectal Surgery Inc.', 'class': 'INDUSTRY'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'John Muir Health', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'St. Joseph Hospital of Orange', 'class': 'OTHER'}, {'name': 'University of California, Irvine', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'University of South Florida', 'class': 'OTHER'}, {'name': 'University of Vermont', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'Creighton University Medical Center', 'class': 'OTHER'}, {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, {'name': 'University of Rochester', 'class': 'OTHER'}, {'name': 'University of Virginia', 'class': 'OTHER'}, {'name': "St. Paul's Hospital", 'class': 'UNKNOWN'}, {'name': 'St. Joseph, Florida', 'class': 'UNKNOWN'}, {'name': 'Cleveland Clinic Florida', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}