Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT05296005
Status:
WITHDRAWN
Last Update Posted:
2025-02-07
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'C029917', 'term': 'dehydroftorafur'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI Decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Standard uptake value SUVmax metrics', 'timeFrame': 'Up to 24 months', 'description': 'Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection.'}, {'measure': 'Standard uptake value SUVpeak Tumor-to-liver metrics', 'timeFrame': 'Up to 24 months', 'description': 'Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection.'}, {'measure': 'Standard uptake value metabolic tumor volume metrics', 'timeFrame': 'Up to 24 months', 'description': 'Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection.'}, {'measure': 'Standard uptake value SUVmax Tumor-to-liver metrics', 'timeFrame': 'Up to 24 months', 'description': 'Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection.'}], 'primaryOutcomes': [{'measure': 'Number of patients able to complete all planned procedures and interventions successfully', 'timeFrame': 'Up to 24 months'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to within 30 days of discontinuation of protocol treatment'}], 'secondaryOutcomes': [{'measure': 'Resident microbiota species associated with higher response', 'timeFrame': 'Up to 24 months'}, {'measure': 'Time to progression', 'timeFrame': 'From date of treatment completion to the event of interest or otherwise censored at last follow-up, assessed up to 12 months'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From date of treatment completion to the event of interest or otherwise censored at last follow-up, assessed up to 12 months', 'description': 'Kaplan-Meier analysis will be used to estimate PFS. PFS will include any failure (local, regional, or distant) or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From date of treatment completion to the event of interest or otherwise censored at last follow-up, assessed up to 12 months', 'description': 'Kaplan-Meier analysis will be used to estimate OS. OS will be death from any cause.'}, {'measure': 'Perfusion and early tumor uptake kinetics of primary tumor using 8F-FDG dPET/CT approaches', 'timeFrame': 'Up to 25 months', 'description': 'To describe the perfusion and early tumor uptake kinetics of primary tumor targets at baseline, during and following systemic chemotherapy and chemoradiation therapies using 18F-FDG dPET/CT approaches'}, {'measure': '18F-FDG dPET/CT to evaluate and characterize residual primary tumor following neoadjuvant chemotherapy and initial chemoradiation therapy for subsequent adaptive boost radiation delivery.', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Stage I Gastric Cancer AJCC v8', 'Clinical Stage II Gastric Cancer AJCC v8', 'Clinical Stage IIA Gastric Cancer AJCC v8', 'Clinical Stage IIB Gastric Cancer AJCC v8', 'Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Clinical Stage III Gastric Cancer AJCC v8', 'Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Gastric Adenocarcinoma', 'Pathologic Stage IB Gastric Cancer AJCC v8', 'Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage II Gastric Cancer AJCC v8', 'Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage IIA Gastric Cancer AJCC v8', 'Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage IIB Gastric Cancer AJCC v8', 'Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage III Gastric Cancer AJCC v8', 'Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage IIIA Gastric Cancer AJCC v8', 'Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage IIIB Gastric Cancer AJCC v8', 'Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8', 'Pathologic Stage IIIC Gastric Cancer AJCC v8', 'Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the feasibility of delivering tailored targeted neoadjuvant therapy with chemotherapy followed by chemoradiation and surgery in patients with gastroesophageal junction gastroesophageal junction (GEJ) and gastric cancer.\n\nII. To assess the toxicity of delivering tailored targeted neoadjuvant therapy with chemotherapy followed by chemoradiation and surgery in patients with GEJ and gastric cancer.\n\nSECONDARY OBJECTIVES:\n\nI. To identify the resident microbiota species associated with higher response to the combination therapy and quantify abundance and diversity of favorable bacterial communities over the course of the therapy.\n\nII. To evaluate local control, progression-free survival, and overall survival at 3, 6, 9, 12 and 24 months after treatment with neoadjuvant chemotherapy and chemoradiation.\n\nIII. To describe the perfusion and early tumor uptake kinetics of primary tumor targets at baseline, during and following systemic chemotherapy and chemoradiation therapies using 18F-fluorodeoxyglucose (18F-FDG) digital photon counting positron emission tomography/computed tomography (dPET/CT) approaches.\n\nIV. To evaluate 18F-FDG dPET/CT to evaluate and characterize residual primary tumor following neoadjuvant chemotherapy and initial chemoradiation therapy for subsequent adaptive boost radiation delivery.\n\nEXPLORATORY OBJECTIVE :\n\nI. To explore FDG dPET standardized uptake value (SUV) metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection.\n\nOUTLINE:\n\nNEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\n\nNEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity.\n\nSURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.\n\nAfter completion of study treatment, patients are followed up for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven, cT2N0-T4aN3M0 (TNM 8th edition), gastric or Siewert II-III GEJ adenocarcinoma\n* Evaluation with endoscopic ultrasound (EUS) and staging laparoscopy prior to enrollment is strongly recommended.\n* Patient should be a candidate for neoadjuvant chemotherapy with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) or fluorouracil and oxaliplatin (FOLFOX).\n* Patients should be \\>= 18 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2\n* Patient should be eligible for surgical intervention\n* T1 N0 disease (assessed by endoscopic ultrasound)\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease\n* Solitary functioning kidney within the potential radiation field\n* Peripheral polyneuropathy \\> National Cancer Institute (NCI) grade II'}, 'identificationModule': {'nctId': 'NCT05296005', 'briefTitle': 'Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction and Gastric Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Total Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction (GEJ) and Gastric Cancers: A Pilot Trial', 'orgStudyIdInfo': {'id': 'OSU-20191'}, 'secondaryIdInfos': [{'id': 'NCI-2021-11289', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (chemotherapy, chemoradiation, surgery)', 'description': 'NEOADJUVANT CHEMOTHERAPY: Patients receive FLOT chemotherapy consisting of docetaxel intravenously (IV) , oxaliplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on day 1 or FOLFOX chemotherapy consisting of oxaliplatin IV and leucovorin IV, and fluorouracil IV continuously over 24 hours on days 1 and 2. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity.\n\nNEOADJUVANT CHEMORADIATION: Within 4 weeks after completing neoadjuvant chemotherapy, patients undergo radiation therapy in 25 fractions over 5 weeks. Patients also receive either fluorouracil IV continuously for 24 hours on days 1-5 or capecitabine orally (PO) twice daily (BID) on days 1-5. Cycles repeat weekly for 5 weeks in the absence of disease progression or unacceptable toxicity.\n\nSURGERY: Within 4-8 weeks after neoadjuvant chemoradiation, patients undergo surgical resection according to tumor location and per surgeon expertise.', 'interventionNames': ['Drug: Capecitabine', 'Drug: Docetaxel', 'Drug: Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin', 'Radiation: Radiation Therapy', 'Procedure: Surgical Procedure']}], 'interventions': [{'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Ro 09-1978/000', 'Xeloda'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Docecad', 'RP56976', 'Taxotere', 'Taxotere Injection Concentrate'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'otherNames': ['5 Fluorouracil', '5 Fluorouracilum', '5 FU', '5-Fluoro-2,4(1H, 3H)-pyrimidinedione', '5-Fluorouracil', '5-Fluracil', '5-Fu', '5FU', 'AccuSite', 'Carac', 'Fluoro Uracil', 'Fluouracil', 'Flurablastin', 'Fluracedyl', 'Fluracil', 'Fluril', 'Fluroblastin', 'Ribofluor', 'Ro 2-9757', 'Ro-2-9757'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['Folinic acid'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['1-OHP', 'Ai Heng', 'Aiheng', 'Dacotin', 'Dacplat', 'Diaminocyclohexane Oxalatoplatinum', 'Eloxatin', 'Eloxatine', 'JM-83', 'Oxalatoplatin', 'Oxalatoplatinum', 'RP 54780', 'RP-54780', 'SR-96669'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}, {'name': 'Surgical Procedure', 'type': 'PROCEDURE', 'otherNames': ['Operation', 'Surgery', 'Surgery Type', 'Surgical', 'Surgical Intervention', 'Surgical Interventions', 'Surgical Procedures', 'Type of Surgery'], 'description': 'Undergo surgical resection', 'armGroupLabels': ['Treatment (chemotherapy, chemoradiation, surgery)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dayssy A Diaz Pardo, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}