Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-07 @ 10:43 PM
Study NCT ID:
NCT03124394
Status:
UNKNOWN
Last Update Posted:
2018-07-20
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010534', 'term': 'Peritoneal Neoplasms'}], 'ancestors': [{'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative surgical complications', 'timeFrame': '90 days', 'description': 'Reporting and grading of postoperative surgical complications (according to Dindo)'}, {'measure': 'Rehospitalisation', 'timeFrame': '90 days', 'description': 'Rehospitalisation: (yes/no), time frame, cause of rehospitalisation'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'Time to recurrence measured since diagnosis/Intervention (in months)'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'All cause mortality since diagnosis/Intervention (in months)'}], 'secondaryOutcomes': [{'measure': 'Measurement of quality of life', 'timeFrame': '5 years', 'description': 'Validated measurements of health-related quality of life according to the EORTC manual in terms of general quality of life: EORTC-QLQ30; disease-specific quality of life: EORTC-CR29 (colorectal cancers), and health-utility (EQ-5D).'}, {'measure': 'Cost', 'timeFrame': '90 days', 'description': 'At the level of individual patient Cost in terms of hospital charges and expenses in Swiss Francs'}, {'measure': 'Revenues', 'timeFrame': '90 days', 'description': 'At the level of individual patient Revenues in Swiss Francs as billed according to the DRG and case-mix index'}, {'measure': 'Cost-utility analysis', 'timeFrame': '90 days', 'description': 'Calculation and comparison of QUALY (quality-adjusted life years derived from EQ-5D) for competing treatment strategies taking advantage of published figures and own data, e.g. cost of a systemic palliative chemotherapy compared to cost of an intraperitoneal chemotherapy'}, {'measure': 'Cost-effectiveness', 'timeFrame': '90 days', 'description': 'Aggregation of costs, charges, and revenues for the whole series and comparison with alternative treatment option as clinically relevant, chemotherapy alone and palliative surgery alone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Carcinomatosis']}, 'descriptionModule': {'briefSummary': 'Evaluation of clinical outcome and economical aspects in the treatment of patients with peritoneal carcinomatosis.', 'detailedDescription': 'Peritoneal carcinomatosis is a dooming finding with no hope for cure and a steadily decrease in quality of life. Cytoreductive surgery with intraperitoneal chemotherapy (CRS HIPEC) offers a small but proven chance for cure. The implementation of a CRS HIPEC and PIPAC programme in a Swiss tertiary care hospital is evaluated.\n\nWhen a patient is deemed non resectable, pressurized intraperitoneal aerosol chemotherapy (PIPAC) administered laparoscopically may confer effective palliation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with peritoneal carcinomatosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women \\>18 years\n* Tumour board decision for CRS and intraoperative chemotherapy\n\nExclusion Criteria:\n\n* Missing Tumour board decision for CRS and intraoperative chemotherapy\n* Pregnancy\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT03124394', 'briefTitle': 'Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Winterthur KSW'}, 'officialTitle': 'Prospective Intraperitoneal Chemotherapy in Carcinomatosis Cohort Study', 'orgStudyIdInfo': {'id': 'Carcinomatosis studyWinterthur'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRS and intraoperative chemotherapy', 'description': 'Patients receiving cytoreductive surgery and intraoperative chemotherapy (HIPEC/PIPAC)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8401', 'city': 'Winterthur', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Michel Adamina, Prof/MD/MSc', 'role': 'CONTACT', 'email': 'michel.adamina@ksw.ch', 'phone': '+41522663634'}], 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'centralContacts': [{'name': 'Michel Adamina, Prof/MD/MSc', 'role': 'CONTACT', 'email': 'Michel.Adamina@ksw.ch', 'phone': '+41522663634'}, {'name': 'Kantonsspital Winterthur', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Michel Adamina, Prof/MD/MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Winterthur KSW'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Winterthur KSW', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}