Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 8:23 PM
Study NCT ID:
NCT05753306
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D005743', 'term': 'Gastrectomy'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C080625', 'term': 'taxane'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D000084262', 'term': 'Hyperthermic Intraperitoneal Chemotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': 'Up to 30 days post-surgery', 'description': 'Recorded as number of days in hospital following surgery.'}, {'measure': '30 day readmission rate', 'timeFrame': 'Up to 30 days post-surgery', 'description': 'Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 30 days post surgery', 'description': 'Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death)'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Intraoperative', 'description': 'Recorded as the time from incision to close'}, {'measure': 'Opioid consumption', 'timeFrame': 'Up to 42 months', 'description': 'Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery.'}, {'measure': 'Nursing reported pain scores', 'timeFrame': 'Up to 42 months', 'description': 'As recorded (mean and max) during hospitalization and post-surgery follow-up visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma', 'Gastroesophageal Junction Adenocarcinoma', 'Metastatic Malignant Neoplasm in the Peritoneum']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Restricted to 18 to 80 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2\n* Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas\n* Absolute neutrophil count \\>= 1,500 / uL\n* Platelets \\>= 50,000 / Ul\n* Serum creatinine \\<= 1.5 mg / dL\n* Adequate nutritional status (Albumin \\>= 3.5)\n* Metastasis confined to the peritoneum:\n\n * Positive peritoneal cytology\n * Peritoneal metastasis on diagnostic laparoscopy\n * Peritoneal metastasis on imaging\n* Response to systemic chemotherapy defined as at least one of the following:\n\n * Reduction (\\>= 30%) in standardized uptake value (SUV) max \\[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\\]\n * Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\\>= 20% decrease in the longest diameter of target lesion) RECIST criteria\n * Reduction ( \\>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology\n * Reduction ( \\>= 30%) in serum tumor markers CEA or CA 19-9\n* Peritoneal Carcinomatosis Index (PCI) =\\< 7 and surgeon deems high likelihood for a complete cytoreduction\n* Body Mass Index (BMI) =\\< 35 kg/m\\^2\n\nExclusion Criteria:\n\n* Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)\n* Malignant ascites at time of study enrollment\n* Comorbidities that would preclude protocol therapy\n* Subjects deemed unable to comply with study and/or follow-up procedures\n* Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity'}, 'identificationModule': {'nctId': 'NCT05753306', 'briefTitle': 'Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial', 'orgStudyIdInfo': {'id': '22-004680'}, 'secondaryIdInfos': [{'id': 'NCI-2023-00431', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '22-004680', 'type': 'OTHER', 'domain': 'Mayo Clinic in Rochester'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (gastrectomy, HIPEC)', 'description': 'Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.', 'interventionNames': ['Drug: Cisplatin', 'Procedure: Computed Tomography', 'Procedure: Gastrectomy', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Positron Emission Tomography', 'Other: Questionnaire Administration', 'Drug: Paclitaxel', 'Drug: Hyperthermic Intraperitoneal Chemotherapy']}], 'interventions': [{'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given via HIPEC', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT scan or PET/CT', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Gastric Resection'], 'description': 'Undergo robotic gastrectomy', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging'], 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging', 'PT'], 'description': 'Undergo PE/CT', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaire', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Taxane', 'Taxol', '5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine', 'Taxol Konzentrat', 'Praxel', 'Abraxane', 'Naveruclif', 'Pazenir'], 'description': 'Given via HIPEC', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}, {'name': 'Hyperthermic Intraperitoneal Chemotherapy', 'type': 'DRUG', 'otherNames': ['HIPEC'], 'description': 'Undergo HIPEC', 'armGroupLabels': ['Treatment (gastrectomy, HIPEC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}, {'name': 'Travis E. Grotz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Clinical Trials Referral Office', 'role': 'CONTACT', 'email': 'mayocliniccancerstudies@mayo.edu', 'phone': '855-776-0015'}], 'overallOfficials': [{'name': 'Travis E Grotz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}