Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT00002593
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D007978', 'term': 'Levamisole'}], 'ancestors': [{'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': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-02', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-30', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare effectiveness of bolus 5-FU, leucovorin, levamisole vs continuous infusion 5-FU, levamisole as adjuvant therapy for patients with colon cancer, measured in overall survival', 'timeFrame': 'At death'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'Until progression'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II colon cancer', 'stage III colon cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '21997132', 'type': 'BACKGROUND', 'citation': "Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. doi: 10.1093/jnci/djr310. Epub 2011 Oct 12."}, {'pmid': '15774775', 'type': 'RESULT', 'citation': 'Poplin EA, Benedetti JK, Estes NC, Haller DG, Mayer RJ, Goldberg RM, Weiss GR, Rivkin SE, Macdonald JS. Phase III Southwest Oncology Group 9415/Intergroup 0153 randomized trial of fluorouracil, leucovorin, and levamisole versus fluorouracil continuous infusion and levamisole for adjuvant treatment of stage III and high-risk stage II colon cancer. J Clin Oncol. 2005 Mar 20;23(9):1819-25. doi: 10.1200/JCO.2005.04.169.'}, {'type': 'RESULT', 'citation': 'Poplin E, Benedetti J, Estes N, et al.: Phase III randomized trial of bolus 5-FU/leucovorin/levamisole versus 5-FU continuous infusion/levamisole as adjuvant therapy for high risk colon cancer (SWOG 9415/INT-0153). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A931, 2000.'}, {'type': 'RESULT', 'citation': 'Leichman CG, Poplin E, Zalupski M, et al.: A pilot trial of infusion 5-fluorouracil with levamisole as adjuvant therapy for stage III colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-460, 196, 1995.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more cancer cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in different ways in treating patients with surgically removed stage II or stage III colon cancer at high risk of recurrence.', 'detailedDescription': 'OBJECTIVES: I. Compare overall and disease free survival in patients with completely resected stage II or III colon cancer randomized to adjuvant chemotherapy with bolus fluorouracil and leucovorin calcium with levamisole vs continuous infusion fluorouracil with levamisole.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, T stage (T1 vs T2 vs T3 vs T4a), N stage (N0 vs N1 vs N2-3), and time from surgery until registration (21-28 vs 29-35 days). Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV immediately followed by fluorouracil IV on days 1 through 5 of weeks 1, 5, 9, 14, 19, and 24, and oral levamisole 3 times a day for 3 days on days 1-3. Courses repeat every 2 weeks for 6 months. Arm II: Patients receive levamisole as in arm I plus fluorouracil by continuous IV infusion for 8 weeks. Treatment with fluorouracil repeats every 10 weeks for 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 9 months and 12 months, then every 6 months for 4 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the study over approximately 5.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS: Histologically proven resectable stage II or III adenocarcinoma of the colon Caudal margin of the primary tumor must lie above the peritoneal reflection Must have pathologic confirmation of either N1-3 (stage III), or if N0, must have T3-T4 (stage II) with bowel obstruction or perforation Obstruction documented as: At least 75% colon or small bowel obstruction on x-ray and/or endoscopy Significant bowel dilatation surgically documented Significant obstruction described in the pathology report Perforation documented by gross operative/pathologic evidence of a colon wall defect with associated abscess or peritonitis Complete en bloc resection by laparotomy required No laparoscopic colectomy without prior surgery on protocol SWOG-9411 No gross or microscopic residual disease No distant peritoneal metastases (stage IV) even if grossly resectable No requirement to open the pelvic peritoneum to define the extent of disease No extrapelvic nodal metastasis unless resected en bloc with the primary tumor No distant metastases No other diagnosis of stage II-III colon cancer within the past 5 years May have undergone complete surgical resection at least 5 years prior to study Completely resected prior or synchronous stage 0-I colon cancer eligible\n\nPATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: WBC (white blood cell) at least 3,500/mm3 Platelet count at least within the lower limit of normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST (angiotensin sensitivity test) no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: No organic brain syndrome, Alzheimer's disease, or other altered mental status No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile patients\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior fluorouracil or other chemotherapy for cancer No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy for cancer Surgery: Complete en bloc resection required (see Disease Characteristics)"}, 'identificationModule': {'nctId': 'NCT00002593', 'briefTitle': 'S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer', 'orgStudyIdInfo': {'id': 'CDR0000063773'}, 'secondaryIdInfos': [{'id': 'SWOG-9415', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'CLB-9498', 'type': 'OTHER', 'domain': 'CALGB'}, {'id': 'INT-0153', 'type': 'OTHER', 'domain': 'NCI'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5-FU/Leucovorin/Levamisole', 'description': 'levamisole hydrochloride: 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; leucovorin calcium: 20 mg/m\\^2/day, IV, Days 1-5 of each cycle; 5-fluorouracil: 425 mg/m\\^2/day, IV, Days 1-5 of each cycle;', 'interventionNames': ['Drug: fluorouracil', 'Drug: leucovorin calcium', 'Drug: levamisole hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infusional 5-FU + Levamisole', 'description': 'levamisole hydrochloride : 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; 5-fluorouracil: 250 mg/m\\^2/day, continuous infusion, daily for 56 days x 3 cycles of 8 weeks.', 'interventionNames': ['Drug: fluorouracil', 'Drug: levamisole hydrochloride']}], 'interventions': [{'name': 'fluorouracil', 'type': 'DRUG', 'otherNames': ['5-fluorouracil', '5-FU', 'NSC-19893'], 'description': 'Given IV as described in Arm Description', 'armGroupLabels': ['5-FU/Leucovorin/Levamisole', 'Infusional 5-FU + Levamisole']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'otherNames': ['Leucovorin', 'Folinic acid', 'NSC-3590'], 'description': 'Given IV as described in Arm description.', 'armGroupLabels': ['5-FU/Leucovorin/Levamisole']}, {'name': 'levamisole hydrochloride', 'type': 'DRUG', 'otherNames': ['Levamisole', 'NSC-177023'], 'description': 'Given as described in arm description', 'armGroupLabels': ['5-FU/Leucovorin/Levamisole', 'Infusional 5-FU + Levamisole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259-5404', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Scottsdale Oncology Program', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94115-0128', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Cancer Center and Cancer Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305-5408', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80209-5031', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'CCOP - Colorado Cancer Research Program, Inc.', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20307-5000', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Sylvester Cancer Center, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital - Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Atlanta (Decatur)', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Chicago (Lakeside)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Illinois Oncology Research Association', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '52403-1206', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Cedar Rapids Oncology Project', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '10309-1016', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Iowa Oncology Research Association', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '51101-1733', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'CCOP - Ochsner', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '49007-3731', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - 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Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein Comprehensive Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center, UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27104-4241', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '27157-1082', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Quain & Ramstad Clinic, P.C.', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58201', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Altru Health Systems', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}, {'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43623-3456', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Toledo Community Hospital Oncology Program', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '17822-2001', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CCOP - Geisinger Clinical and Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '57709', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Rapid City Regional Hospital', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '57105-1080', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'CCOP - Sioux Community Cancer Consortium', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee, Memphis Cancer Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '05401-3498', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Vermont Cancer Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - Marshfield Medical Research and Education Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53295', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Milwaukee (Zablocki)', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'S4S 6X3', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Saskatchewan Cancer Agency', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'zip': '00927-5800', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Veterans Affairs Medical Center - San Juan', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '0001', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Pretoria Academic Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'overallOfficials': [{'name': 'Elizabeth A. Poplin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}, {'name': 'Robert J. Mayer, MD, FACP', 'role': 'STUDY_CHAIR', 'affiliation': 'Dana-Farber Cancer Institute'}, {'name': 'Daniel G. Haller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}, {'name': 'Richard M. Goldberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Cancer and Leukemia Group B', 'class': 'NETWORK'}, {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, {'name': 'North Central Cancer Treatment Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}