Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:48 PM
Study NCT ID:
NCT05174169
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic 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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1912}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ctDNA positive status (TTPos)', 'timeFrame': 'Time from randomization to the first TTPos event, a maximum of 3 years', 'description': 'TTPos is defined as time from randomization until ctDNA positive event: TTPos events are first ctDNA positive result after randomization for the immediate adjuvant chemo arm (Arm 1), 2nd ctDNA positive result after randomization for the delayed adjuvant chemo (Arm 2) and recurrence without a positive ctDNA result for both arms.'}, {'measure': 'Disease-Free Survival (DFS)', 'timeFrame': 'Time from randomization to disease-free survival event, a maximum of 5 years]', 'description': 'Time from randomization to first disease-free survival event (recurrence, second primary colorectal cancer or death from any cause).'}], 'secondaryOutcomes': [{'measure': 'Baseline post-surgery ctDNA positivity rate', 'timeFrame': 'At time of randomization', 'description': 'percentage of patients with ctDNA positive results post-surgery at study entry.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Time from randomization to death, a maximum of 5 years.', 'description': 'Time from randomization to death of any cause.'}, {'measure': 'Recurrence', 'timeFrame': 'Time from randomization to disease recurrence, a maximum of 5 years', 'description': 'Time from randomization to disease recurrence.'}, {'measure': 'Compliance with adjuvant chemotherapy', 'timeFrame': 'from randomization to the last cycle of chemotherapy, a maximum of 6 months.', 'description': 'number of cycles of chemotherapy received.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ctDNA positive', 'ctDNA negative', 'Adjuvant Chemotherapy', 'Natera', 'Signatera', 'mFOLFOX6', 'Stage III', 'CAPOX', 'mFOLFIRINOX', 'Oxaliplatin', '5-Fluorouracil (5-FU)', 'Capecitabine', 'Leucovorin', 'Irinotecan', 'Stage II'], 'conditions': ['Stage III Colon Cancer']}, 'descriptionModule': {'briefSummary': 'This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.', 'detailedDescription': 'Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe patient must have an ECOG performance status of 0 or 1.\n\nPatients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.\n\nNo radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).\n\nThe distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).\n\nThe patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.\n\nThe resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1/Study entry and before Step2/Randomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery).\n\nTumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.\n\nThe treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).\n\nThe interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery.\n\nAvailability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.\n\nAdequate hematologic function within 28 days before Step 1/Study entry defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000/mm3; and\n* Hemoglobin must be greater than or equal to 9 g/dL.\n\nAdequate hepatic function within 28 days before Step 1/Study entry defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before Step 1/Study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW).\n\nHIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1/Study entry must be negative (for women of childbearing potential only).\n\nPatients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.\n\nEligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPatient must have developed a ctDNA +ve assay during serial monitoring.\n\nPatient's willingness to be re-randomized affirmed.\n\nThe patient must continue to have an ECOG performance status of 0 or 1.\n\nNo radiographic evidence of overt metastatic disease.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).\n\nAdequate hematologic function within 28 days before second randomization defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000/mm3; and\n* Hemoglobin must be greater than or equal to 9 g/dL.\n\nAdequate hepatic function within 28 days before second randomization defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL)\n\nExclusion Criteria:\n\nColon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).\n\nPathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.\n\nTumor-related bowel perforation.\n\nHistory of prior invasive colon malignancy, regardless of disease-free interval.\n\nHistory of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary.\n\nAny prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization.\n\nOther invasive malignancy within 5 years before Step 1/Study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.\n\nSynchronous primary rectal and/ or colon cancers.\n\nPatients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\nSensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0.\n\nBlood transfusion within two weeks before collection of blood for central ctDNA testing.\n\nActive seizure disorder uncontrolled by medication.\n\nActive or chronic infection requiring systemic therapy.\n\nKnown homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.\n\nPatients known to have Gilbert's Syndrome or homozygosity for UGT1A1\\*28 polymorphism.\n\nPregnancy or lactation at the time of Step 1/Study entry.\n\nCo-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).\n\nIneligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPregnancy or lactation at the time of randomization.\n\nNo longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator."}, 'identificationModule': {'nctId': 'NCT05174169', 'acronym': 'CIRCULATE-US', 'briefTitle': 'Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease', 'organization': {'class': 'OTHER', 'fullName': 'NRG Oncology'}, 'officialTitle': 'Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease', 'orgStudyIdInfo': {'id': 'NRG-GI008'}, 'secondaryIdInfos': [{'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'NRG-GI008', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'NCI-2021-08397', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort A - Arm 1 (ctDNA-ve)', 'description': 'Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles\n\nOR\n\nOxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles', 'interventionNames': ['Device: Signatera test', 'Drug: mFOLFOX6 3-6 month', 'Drug: CAPOX 3 month']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A - Arm 2 (ctDNA-ve)', 'description': 'Serial ctDNA monitoring no treatment', 'interventionNames': ['Device: Signatera test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort B - Arm 3 (ctDNA+ve)', 'description': 'Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles\n\nOR\n\nOxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles', 'interventionNames': ['Device: Signatera test', 'Drug: mFOLFOX6 6 month', 'Drug: CAPOX 6 month']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B - Arm 4 (ctDNA+ve)', 'description': 'Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles', 'interventionNames': ['Device: Signatera test', 'Drug: mFOLFIRINOX']}], 'interventions': [{'name': 'Signatera test', 'type': 'DEVICE', 'description': 'Central ctDNA testing for all patients', 'armGroupLabels': ['Cohort A - Arm 1 (ctDNA-ve)', 'Cohort A - Arm 2 (ctDNA-ve)', 'Cohort B - Arm 3 (ctDNA+ve)', 'Cohort B - Arm 4 (ctDNA+ve)']}, {'name': 'mFOLFOX6 3-6 month', 'type': 'DRUG', 'description': 'Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 6-12 cycles', 'armGroupLabels': ['Cohort A - Arm 1 (ctDNA-ve)']}, {'name': 'CAPOX 3 month', 'type': 'DRUG', 'description': 'Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 4 cycles', 'armGroupLabels': ['Cohort A - Arm 1 (ctDNA-ve)']}, {'name': 'mFOLFIRINOX', 'type': 'DRUG', 'description': 'Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + Irinotecan 150 mg/m2 IV continuous infusion (30-90 minutes) + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles', 'armGroupLabels': ['Cohort B - Arm 4 (ctDNA+ve)']}, {'name': 'mFOLFOX6 6 month', 'type': 'DRUG', 'description': 'Oxaliplatin 85 mg/m2 IV + Leucovorin 400mg/m2 IV + 5-Fluorouracil (5-FU) 400mg/m2 bolus + 5-Fluorouracil (5-FU) 2400mg/m2 IV continuous infusion over 46-48 hours (total dose) Day1 every 2 weeks for 12 cycles', 'armGroupLabels': ['Cohort B - Arm 3 (ctDNA+ve)']}, {'name': 'CAPOX 6 month', 'type': 'DRUG', 'description': 'Oxaliplatin 130 mg/m2 IV Day 1 every 3 weeks + Capecitabine 1000 mg/m2 BID by mouth days 1-14 every 3 weeks for 8 cycles', 'armGroupLabels': ['Cohort B - Arm 3 (ctDNA+ve)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'charlesbaldwin@uabmc.edu', 'phone': '205-895-1816'}, {'name': 'Midhun Malla', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36532', 'city': 'Fairhope', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '251-435-4584'}, {'name': 'Prajwol Pathak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Hospital', 'geoPoint': {'lat': 30.52297, 'lon': -87.90333}}, {'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '251-435-3942'}, {'name': 'Prajwol Pathak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'pfrancisco@usouthal.edu', 'phone': '251-445-9870'}, {'name': 'Ahmed Abdalla', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '86401', 'city': 'Kingman', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'research@sncrf.org', 'phone': '702-384-0013'}, {'name': 'John A. Ellerton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kingman Regional Medical Center', 'geoPoint': {'lat': 35.18944, 'lon': -114.05301}}, {'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ResearchInstituteInquiries@CommonSpirit.org', 'phone': '720-874-1881'}, {'name': 'Shahzad Siddique', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cancer Center at Saint Joseph's", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Hospital in Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'UACC-IIT@uacc.arizona.edu'}, {'name': 'Aaron J. Scott', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'UACC-IIT@uacc.arizona.edu'}, {'name': 'Aaron J. Scott', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arizona Cancer Center-North Campus', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72903', 'city': 'Fort Smith', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-378-9373'}, {'name': 'Jay W. Carlson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy Hospital Fort Smith', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'status': 'SUSPENDED', 'country': 'United States', 'facility': 'CHI Saint Vincent Cancer Center Hot Springs', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Emily.Carvell@bmhcc.org', 'phone': '870-936-7066'}, {'name': 'Sohail A. Minhas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '501-686-8274'}, {'name': 'Jonathan A. Laryea', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'clinical.trials@kp.org', 'phone': '800-398-3996'}, {'name': 'Gary L. Buchschacher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Anaheim', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '94531', 'city': 'Antioch', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Kpoct@kp.org', 'phone': '877-642-4691'}, {'name': 'Tatjana Kolevska', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kaiser Permanente-Deer Valley Medical Center', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '93420', 'city': 'Arroyo Grande', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ResearchInstituteInquiries@CommonSpirit.org', 'phone': '720-874-1881'}, {'name': 'Shahzad Siddique', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mission Hope Medical Oncology - Arroyo Grande', 'geoPoint': {'lat': 35.11859, 'lon': -120.59073}}, {'zip': '93420', 'city': 'Arroyo Grande', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'research@sncrf.org', 'phone': '702-384-0013'}, {'name': 'John A. Ellerton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PCR Oncology', 'geoPoint': {'lat': 35.11859, 'lon': -120.59073}}, {'zip': '95602', 'city': 'Auburn', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org'}, {'name': 'Jorge A. Garcia-Young', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sutter Auburn Faith Hospital', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'clinicalresearch@sutterhealth.org'}, {'name': 'Jorge A. 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