Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00014118
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2001-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2001-04-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organ preservation rate'}, {'measure': 'Feasibility and toxicity'}, {'measure': 'Utility of pre- and post-treatment organ function instruments'}, {'measure': 'Disease-free survival and patterns of failure'}, {'measure': 'Objective tumor response rate (complete and partial response)'}, {'measure': 'Changes in quality of life'}, {'measure': 'Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome'}]}, 'conditionsModule': {'keywords': ['stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '18270337', 'type': 'RESULT', 'citation': 'Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100(4):261-9. doi: 10.1093/jnci/djn011. Epub 2008 Feb 12.'}, {'pmid': '17761982', 'type': 'RESULT', 'citation': 'Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Eastern Cooperative Oncology Group Study E2399. J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951.'}, {'type': 'RESULT', 'citation': 'Fakhry C, Westra W, Li S, et al.: Prognostic significance of human papillomavirus (HPV) tumor status for patients with head and neck squamous cell carcinoma (HNSCC) in a prospective, multi-center phase II clinical trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-6000, 299s, 2007.'}, {'type': 'RESULT', 'citation': 'Cmelak AJ, Li S, Murphy B, et al.: Locally advanced resectable larynx (L) or oropharynx (OP) cancer: updated results of organ preservation trial ECOG 2399. [Abstract] J Clin Oncol 24 (Suppl 18): A-5527, 286s, 2006.'}, {'type': 'RESULT', 'citation': 'Murphy BA, Smith K, Cmelak A, et al.: Swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] J Clin Oncol 24 (Suppl 18): A-5524, 2006.'}, {'type': 'RESULT', 'citation': 'Murphy BA, Smith K, Dowling E, et al.: Baseline swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2005, 2003.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the organ preservation rate in patients with stage III or IV squamous cell carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed by paclitaxel with concurrent radiotherapy.\n* Determine the feasibility and toxicity of this regimen in these patients.\n* Determine the utility of pre- and post-treatment organ function instruments on swallowing ability and voice quality in patients treated with this regimen.\n* Determine the disease-free survival and patterns of failure of patients treated with this regimen.\n* Determine the objective tumor response rate (complete and partial response) in these patients following treatment with 2 courses of induction therapy with paclitaxel and carboplatin.\n* Determine changes in quality of life of patients treated with this regimen.\n* Determine whether the presence of human papilloma virus infection and p-glycoprotein correlates with outcome in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to disease site (larynx vs oropharynx).\n\nPatients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of induction therapy, patients with responding or stable disease receive paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly, for 7 weeks beginning on day 1.\n\nWithin 6-8 weeks after completion of therapy, patients who initially had bulky neck disease (N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection. Patients with N1-N2 disease with complete response may also undergo neck dissection. Patients with initial complete response who recur at the primary site undergo surgical salvage.\n\nQuality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24 months after completion of all therapy.\n\nPatients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.\n\nPROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx\n\n * No recurrent disease\n * No evidence of distant metastasis\n* Resectable disease, defined as follows:\n\n * High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)\n * No extension to root of tongue (for disease of the base of tongue)\n * No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall)\n * No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)\n * No trismus (for disease of the tonsil, soft palate, or pharyngeal wall)\n * No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis)\n * For disease of the supraglottis, glottis, or subglottis:\n\n * No base of the tongue invasion greater than 2 cm\n * No tumor extension through cartilage to involve strap muscles of the neck\n * No tumor fixation to prevertebral fascia\n * No involvement of the carotid artery\n * No fixed nodal disease with involvement of the deep neck\n * Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx\n* Measurable disease\n\n * \\- Lesions accurately measured in at least one dimension as \\> 20 mm (2.0 cm) with conventional techniques or as \\> 10 mm (1.0 cm) with spiral CT scan\n * Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion\n* No other concurrent head and neck neoplasms\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Creatinine less than 3.0 mg/dL\n* Calcium normal\n\nCardiovascular\n\n* No significant cardiac disease\n* No uncontrolled hypertension\n* No unstable angina\n* No congestive heart failure\n* No myocardial infarction within the past year\n* No serious cardiac arrhythmias requiring medication\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 3 months after study completion\n* No significant detectable infection\n* No history of allergy to drugs containing Cremophor EL\n* No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin\n* No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy\n* No concurrent amifostine\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy above the clavicles\n\nSurgery\n\n* No prior surgery to the primary tumor except biopsy or debulking\n\nOther\n\n* No concurrent experimental mucosal protectants'}, 'identificationModule': {'nctId': 'NCT00014118', 'briefTitle': 'Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx', 'orgStudyIdInfo': {'id': 'CDR0000068468'}, 'secondaryIdInfos': [{'id': 'U10CA021115', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021115', 'type': 'NIH'}, {'id': 'ECOG-2399'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'paclitaxel', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cancer Institute - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33804-5000', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Watson Clinic, LLC', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hematology and Oncology Associates', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mercy Hospital and Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ingalls Cancer Care Center at Ingalls Memorial Hospital', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '60432', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Center for Hematology/Oncology', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care and Hematology Specialists of Chicagoland - Niles', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hematology Oncology Associates - Skokie', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hematology/Oncology of the North Shore at Gross Point Medical Center', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology Associates, LLP', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center - Sioux City', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': "St. Luke's Regional Medical Center", 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '66720', 'city': 'Chanute', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Chanute', 'geoPoint': {'lat': 37.67921, 'lon': -95.4572}}, {'zip': '67801', 'city': 'Dodge City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Dodge City', 'geoPoint': {'lat': 37.7528, 'lon': -100.01708}}, {'zip': '67042', 'city': 'El Dorado', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - El Dorado', 'geoPoint': {'lat': 37.81724, 'lon': -96.86225}}, {'zip': '67068', 'city': 'Kingman', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Kingman', 'geoPoint': {'lat': 37.64585, 'lon': -98.11367}}, {'zip': '67901', 'city': 'Liberal', 'state': 'Kansas', 'country': 'United States', 'facility': 'Southwest Medical Center', 'geoPoint': {'lat': 37.04308, 'lon': -100.921}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Newton', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '67357', 'city': 'Parsons', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Parsons', 'geoPoint': {'lat': 37.34034, 'lon': -95.26108}}, {'zip': '67124', 'city': 'Pratt', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Pratt', 'geoPoint': {'lat': 37.64391, 'lon': -98.73759}}, {'zip': '67042', 'city': 'Salina', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Salina', 'geoPoint': {'lat': 38.84028, 'lon': -97.61142}}, {'zip': '67152', 'city': 'Wellington', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Wellington', 'geoPoint': {'lat': 37.2653, 'lon': -97.37171}}, {'zip': '67203', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Associates in Womens Health, PA - North Review', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67208', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Medical Arts Tower', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Cancer Center at Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wesley Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67156', 'city': 'Winfield', 'state': 'Kansas', 'country': 'United States', 'facility': 'Cancer Center of Kansas, PA - Winfield', 'geoPoint': {'lat': 37.23975, 'lon': -96.99559}}, {'zip': '49001', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Borgess Medical Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49007-3731', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Cancer Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Methodist Hospital', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '44710-1799', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aultman Cancer Center at Aultman Hospital', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Cancer Care Center at MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18840', 'city': 'Sayre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Guthrie Cancer Center at Guthrie Clinic Sayre', 'geoPoint': {'lat': 41.97896, 'lon': -76.5155}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Mary Babb Randolph Cancer Center at West Virginia University Hospitals', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '54301-3526', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Green Bay Oncology, Limited at St. Mary's Hospital", 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Mary's Hospital Medical Center - Green Bay", 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54307-3508', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'St. Vincent Hospital Regional Cancer Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54143', 'city': 'Marinette', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Bay Area Cancer Care Center at Bay Area Medical Center', 'geoPoint': {'lat': 45.09998, 'lon': -87.63066}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic - Marshfield Center', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '54868', 'city': 'Rice Lake', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic - Indianhead Center', 'geoPoint': {'lat': 45.50607, 'lon': -91.73823}}], 'overallOfficials': [{'name': 'Anthony J. Cmelak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}