Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT04956068
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PIPAC for Peritoneal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-06-29', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with major toxicities of at least CTCAE Grade 3 and above', 'timeFrame': 'Up to 4 weeks after each PIPAC procedure', 'description': 'To determine and safety and feasibility of PIPAC in patients with PM. Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.'}, {'measure': 'Number of patients with minor toxicities of CTCAE Grade 1 and 2', 'timeFrame': 'Up to 4 weeks after each PIPAC procedure', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) measures Grade 1 to 5, with higher grade indicating greater severity.'}, {'measure': 'Length of hospitalisation stay for each PIPAC procedure', 'timeFrame': 'Through study completion, an average of half a year'}], 'secondaryOutcomes': [{'measure': 'Intra-operative Peritoneal Carcinomatosis Index (PCI) score', 'timeFrame': 'During each PIPAC procedure', 'description': 'To examine the clinical response of PM after PIPAC. PCI score from 0 to 39 with a higher number representing a greater amount of disease present in the peritoneum.'}, {'measure': 'Ascites volume', 'timeFrame': 'During each PIPAC procedure', 'description': 'To examine the clinical response of PM after PIPAC'}, {'measure': 'Peritoneal Regression Grading Score (PRGS) from PM biopsy', 'timeFrame': 'At each PIPAC procedure', 'description': 'To examine the clinical response of PM after PIPAC'}, {'measure': 'Quality of Life Assessment using Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire', 'timeFrame': 'At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)', 'description': 'Range: 0-108. A high score represents a better health state'}, {'measure': 'Quality of Life Assessment using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Quality of life questionnaire', 'timeFrame': 'At 4 time points - Baseline (before any PIPAC procedure), pre-2nd PIPAC (Before 2nd PIPAC procedure), pre-3rd PIPAC (before 3rd PIPAC procedure) and 4 weeks post-3rd PIPAC (4 weeks after 3rd PIPAC procedure)', 'description': 'Range: 0-100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.'}, {'measure': 'Progression free survival', 'timeFrame': 'From the start of the first PIPAC procedure, up to 5 years'}, {'measure': 'Overall survival', 'timeFrame': 'From the start of the first PIPAC procedure, up to 5 years'}, {'measure': 'Percentage of patients that convert to curative surgery', 'timeFrame': 'From the start of the first PIPAC procedure, up to 24 weeks ± 4 weeks', 'description': '(Only applicable for Extensive PM group)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peritoneal Metastases']}, 'descriptionModule': {'briefSummary': 'Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Unesectable PM Group:\n\n* Age ≥ 21 years old\n* ECOG \\< 3\n* Fit for systemic chemotherapy treatment\n* Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L\n* Adequate renal function (e-GFR \\> 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR \\> 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)\n* Adequate liver function (Total bilirubin \\< 1.5 upper limit of normal; ALT and AST\\< 3 upper limit of normal)\n* No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin\n* No contraindications to general anaesthesia and diagnostic laproscopy procedure\n* Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin)\n* Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries\n* Peritoneal-dominant metastatic disease\n\nFor the Extensive PM Group:\n\nAll the above mentioned criteria as for the unresectable group, with the addition of the following:\n\n* Not suitable for curative cytoreductive surgery (CRS) \\& hyperthermic intraperitoneal chemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI \\> 18 in LGI, PCI \\> 6 in UGI ECOG \\< 3\n* In UGI PM patients, progression while on bidirectional chemotherapy\n\nExclusion Criteria:\n\n* Patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases\n* Any medical or psychiatric condition(s) which would preclude informed consent\n* Patient is pregnant or nursing\n* GI PM patients with PCI \\>6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)'}, 'identificationModule': {'nctId': 'NCT04956068', 'briefTitle': 'PIPAC for Peritoneal Metastases', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Centre, Singapore'}, 'officialTitle': 'Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases', 'orgStudyIdInfo': {'id': 'PIPAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unresectable PM group', 'description': 'Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.', 'interventionNames': ['Combination Product: PIPAC']}, {'type': 'EXPERIMENTAL', 'label': 'Extensive PM group', 'description': 'Patients who have significant volume of peritoneal disease are treated with the intent for potential conversion to curative surgery. Role of PIPAC is as an adjunct to systemic chemotherapy to downstage peritoneal metastases.', 'interventionNames': ['Combination Product: PIPAC']}], 'interventions': [{'name': 'PIPAC', 'type': 'COMBINATION_PRODUCT', 'description': 'A novel drug delivery system using the CapnoPen device which allows the aerolisation of chemotherapeutic agents within the peritoneal cavity. PIPAC procedure will be carried out with either oxaliplatin or doxorubicin/ cisplatin.', 'armGroupLabels': ['Extensive PM group', 'Unresectable PM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169690', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'National Cancer Center Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Claramae Chia, MBBS', 'role': 'CONTACT', 'email': 'claramae.chia.s.l@singhealth.com.sg', 'phone': '+65 6436 8000'}], 'overallOfficials': [{'name': 'Claramae Chia, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Centre, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}