Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT00079066
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 572}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2009-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2004-03-08', 'studyFirstSubmitQcDate': '2004-03-08', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Objective response rate'}, {'measure': 'Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire -C30 (EORTC QLQ-C30)'}, {'measure': 'Health utilities by Health Utilities Index 13 (HU 13)'}, {'measure': 'Economic evaluation'}, {'measure': 'Safety profile'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'stage IV colon cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'stage IV rectal cancer'], 'conditions': ['Colorectal Cancer', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '36881786', 'type': 'BACKGROUND', 'citation': "Gupta A, O'Callaghan CJ, Zhu L, Jonker DJ, Wong RPW, Colwell B, Moore MJ, Karapetis CS, Tebbutt NC, Shapiro JD, Tu D, Booth CM. Evaluating the Time Toxicity of Cancer Treatment in the CCTG CO.17 Trial. JCO Oncol Pract. 2023 Jun;19(6):e859-e866. doi: 10.1200/OP.22.00737. Epub 2023 Mar 7."}, {'pmid': '19273701', 'type': 'RESULT', 'citation': "Au HJ, Karapetis CS, O'Callaghan CJ, Tu D, Moore MJ, Zalcberg JR, Kennecke H, Shapiro JD, Koski S, Pavlakis N, Charpentier D, Wyld D, Jefford M, Knight GJ, Magoski NM, Brundage MD, Jonker DJ. Health-related quality of life in patients with advanced colorectal cancer treated with cetuximab: overall and KRAS-specific results of the NCIC CTG and AGITG CO.17 Trial. J Clin Oncol. 2009 Apr 10;27(11):1822-8. doi: 10.1200/JCO.2008.19.6048. Epub 2009 Mar 9."}, {'type': 'RESULT', 'citation': 'Jonker DJ, Karapetis C, Harbison C, et al.: High epiregulin (EREG) gene expression plus K-ras wild-type (WT) status as predictors of cetuximab benefit in the treatment of advanced colorectal cancer (ACRC): results from NCIC CTG CO.17-A phase III trial of cetuximab versus best supportive care (BSC).. [Abstract] J Clin Oncol 27 (Suppl 15): A-4016, 2009.'}, {'pmid': '20603436', 'type': 'RESULT', 'citation': "Asmis TR, Powell E, Karapetis CS, Jonker DJ, Tu D, Jeffery M, Pavlakis N, Gibbs P, Zhu L, Dueck DA, Whittom R, Langer C, O'Callaghan CJ. Comorbidity, age and overall survival in cetuximab-treated patients with advanced colorectal cancer (ACRC)--results from NCIC CTG CO.17: a phase III trial of cetuximab versus best supportive care. Ann Oncol. 2011 Jan;22(1):118-126. doi: 10.1093/annonc/mdq309. Epub 2010 Jul 5."}, {'pmid': '18946061', 'type': 'RESULT', 'citation': "Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. doi: 10.1056/NEJMoa0804385."}, {'type': 'RESULT', 'citation': 'Mittmann N, Au HJ, Tu D, et al.: A prospective economic analysis of cost-effectiveness of cetuximab for metastatic colorectal cancer patients from the NCIC CTG and AGITG CO.17 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-6528, 2008.'}, {'type': 'RESULT', 'citation': "O'Callaghan CJ, Tu D, Karapetis CS, et al.: The relationship between the development of rash and clinical and quality of life outcomes in colorectal cancer patients treated with cetuximab in NCIC CTG CO.17. [Abstract] J Clin Oncol 26 (Suppl 15): A-4130, 2008."}, {'type': 'RESULT', 'citation': 'Jonker DJ, Karapetis CS, Moore M, et al.: Randomized phase III trial of cetuximab monotherapy plus best supportive care (BSC) versus BSC alone in patients with pretreated metastatic epidermal growth factor receptor (EGFR)-positive colorectal carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) and the Australasian Gastro-Intestinal Trials Group (AGITG). [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. 2007.'}, {'pmid': '18003960', 'type': 'RESULT', 'citation': "Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, Berry SR, Krahn M, Price T, Simes RJ, Tebbutt NC, van Hazel G, Wierzbicki R, Langer C, Moore MJ. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007 Nov 15;357(20):2040-8. doi: 10.1056/NEJMoa071834."}, {'pmid': '40215447', 'type': 'DERIVED', 'citation': "Nicholls DL, Xu MC, Zhan L, Sharma D, Hueniken K, Chiasson K, Wahba M, Brown MC, Grant B, Shapiro J, Karapetis CS, Simes J, Jonker D, Tu D, O'Callaghan C, Chen E, Liu G. Machine Learning Models of Early Longitudinal Toxicity Trajectories Predict Cetuximab Concentration and Metastatic Colorectal Cancer Survival in the Canadian Cancer Trials Group/AGITG CO.17/20 Trials. JCO Clin Cancer Inform. 2025 Apr;9:e2400114. doi: 10.1200/CCI.24.00114. Epub 2025 Apr 11."}, {'pmid': '38656931', 'type': 'DERIVED', 'citation': "Gupta A, O'Callaghan CJ, Zhu L, Jonker DJ, Wong RPW, Colwell B, Moore MJ, Karapetis CS, Tebbutt NC, Shapiro JD, Tu D, Booth CM. The association of health-care contact days with physical function and survival in CCTG/AGITG CO.17. J Natl Cancer Inst. 2024 Aug 1;116(8):1313-1318. doi: 10.1093/jnci/djae077."}, {'pmid': '33087330', 'type': 'DERIVED', 'citation': "Loree JM, Dowers A, Tu D, Jonker DJ, Edelstein DL, Quinn H, Holtrup F, Price T, Zalcberg JR, Moore MJ, Karapetis CS, O'Callaghan CJ, Waring P, Kennecke HF, Hamilton SR, Kopetz S. Expanded Low Allele Frequency RAS and BRAF V600E Testing in Metastatic Colorectal Cancer as Predictive Biomarkers for Cetuximab in the Randomized CO.17 Trial. Clin Cancer Res. 2021 Jan 1;27(1):52-59. doi: 10.1158/1078-0432.CCR-20-2710. Epub 2020 Oct 21."}, {'pmid': '30466310', 'type': 'DERIVED', 'citation': "Hay AE, Pater JL, Corn E, Han L, Camacho X, O'Callaghan C, Chong N, Bell EN, Tu D, Earle CC. Pilot study of the ability to probabilistically link clinical trial patients to administrative data and determine long-term outcomes. Clin Trials. 2019 Feb;16(1):14-17. doi: 10.1177/1740774518815653. Epub 2018 Nov 22."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.\n\nPURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone.\n\nSecondary\n\n* Compare the time to disease progression in patients treated with these regimens.\n* Compare the objective response rate in patients treated with these regimens.\n* Compare the quality of life of patients treated with these regimens.\n* Compare the health utilities of patients treated with these regimens.\n* Conduct a comparative economic evaluation in patients treated with these regimens.\n* Determine the safety profile of cetuximab in these patients.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive an initial loading dose of cetuximab IV over 120 minutes on day 1. Patients continue to receive maintenance infusions of cetuximab IV over 60 minutes weekly. Patients also receive best supportive care, defined as measures designed to provide palliation of symptoms and improve quality of life as much as possible.\n* Arm II: Patients receive best supportive care as in arm I. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed at baseline, and then at 4, 8, 16, and 24 weeks (or until deterioration to ECOG PS 4 or hospitalization for end-of-life care).\n\nPatients are followed every 4 weeks.\n\nPROJECTED ACCRUAL: A total of 500 patients (250 per treatment arm) will be accrued for this study within 20 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed colorectal cancer\n\n * Metastatic disease\n* Epidermal growth factor receptor (EGFR)-positive by immunochemistry\n* Measurable or evaluable disease\n* Not amenable to standard curative therapy\n\n * Best supportive care is the only available option\n* Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting\n\n * Combination therapy with oxaliplatin or irinotecan allowed\n* Must have failed\\* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens\n* No symptomatic CNS metastases NOTE: \\*Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 16 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* See Disease Characteristics\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 75,000/mm\\^3\n* Hemoglobin ≥ 8.0 g/dL\n\nHepatic\n\n* AST and ALT ≤ 5 times upper limit of normal (ULN)\n* Bilirubin ≤ 2.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No uncontrolled angina\n* No arrhythmias\n* No cardiomyopathy\n* No congestive heart failure\n* No myocardial infarction\\* within the past 6 months NOTE: \\*Pre-treatment ECG as only evidence of infarction is allowed\n\nPulmonary\n\n* No severe restrictive lung disease\n* No interstitial lung disease by chest x-ray\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment\n* No active pathological condition that would preclude study participation\n* No psychological or geographical condition that would preclude study compliance\n* No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior cetuximab\n* No prior murine monoclonal antibody therapy (e.g., edrecolomab)\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy and recovered\n* No concurrent chemotherapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy and recovered\n* Concurrent palliative radiotherapy allowed except to index lesions\n\nSurgery\n\n* At least 4 weeks since prior major surgery and recovered\n\nOther\n\n* No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib)\n* More than 30 days since prior experimental therapeutic agents\n* More than 4 weeks since prior investigational agents\n* No concurrent enrollment in another clinical study\n* No other concurrent EGFR-targeted therapy\n* No other concurrent non-cytotoxic experimental agents'}, 'identificationModule': {'nctId': 'NCT00079066', 'briefTitle': 'Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma', 'orgStudyIdInfo': {'id': 'CO17'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-CO17', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'AGITG-CAN-NCIC-CO17', 'type': 'OTHER', 'domain': 'AGITG'}, {'id': 'BMS-CA225-025', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}, {'id': 'IMCL-CAN-NCIC-CO17', 'type': 'OTHER', 'domain': 'ImClone Systems Incorporated'}, {'id': 'CDR0000353486', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cetuximab', 'type': 'BIOLOGICAL'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1450', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'NHMRC Clinical Trials Centre', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute at University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V1Y 5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Centre for the Southern Interior', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Fraser Valley Cancer Centre at British Columbia Cancer Agency', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 6V5', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Island Cancer Centre', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E1C 6ZB', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Newfoundland Cancer Treatment and Research Foundation', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K8N 5K5', 'city': 'Belleville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Belleville General Hospital', 'geoPoint': {'lat': 44.16682, 'lon': -77.38277}}, {'zip': 'K7L 5P9', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Centre of Southeastern Ontario at Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N2G 1G3', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Grand River Regional Cancer Centre at Grand River Hospital', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program at London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital Regional Cancer Centre - General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L2R 5K3', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Health Sciences Hospital - Niagara', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'P7B 6V4', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto East General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital - Toronto", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital - Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6R 1B5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Health Centre - Toronto", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Windsor Regional Cancer Centre at Windsor Regional Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'C1A 8T5', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'Prince Edward Island Cancer Centre at Queen Elizabeth Hospital', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Charles Lemoyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H2L 4MI', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Cancer Centre at McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Du Sacre-Coeur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre at Pasqua Hospital', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': 'S7N 4H4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatoon Cancer Centre at the University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Derek Jonker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ottawa Regional Cancer Centre'}, {'name': 'Chris Karapetis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Health and Medical Research Council, Australia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Australasian Gastro-Intestinal Trials Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}