Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
25 participants
INTERVENTIONAL
2021-05-20
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unresectable PM group
Patients who have progressed on conventional systemic therapy and PIPAC is used as a palliative strategy.
PIPAC
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.
Extensive PM group
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.
PIPAC
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.
Interventions
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PIPAC
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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 21 years old
* ECOG \< 3
* Fit for systemic chemotherapy treatment
* Adequate bone marrow function (haemoglobin ≥ 8.0 mmol/L, neutrophils ≥ 1.5X109/L, platelets ≥ 100X109/L
* Adequate renal function (e-GFR \> 30mls/min for patients undergoing PIPAC with oxaliplatin; e-GFR \> 60mls/min for patients undergoing PIPAC with Doxorubicine/Cisplatin)
* Adequate liver function (Total bilirubin \< 1.5 upper limit of normal; ALT and AST\< 3 upper limit of normal)
* No contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin
* No contraindications to general anaesthesia and diagnostic laproscopy procedure
* Normal left ventricular ejection fraction (for patients undergoing PIPAC with doxorubicin/ cisplatin)
* Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcoma primaries
* Peritoneal-dominant metastatic disease
For the Extensive PM Group:
All the above mentioned criteria as for the unresectable group, with the addition of the following:
* 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
* In UGI PM patients, progression while on bidirectional chemotherapy
Exclusion Criteria
* Any medical or psychiatric condition(s) which would preclude informed consent
* Patient is pregnant or nursing
* GI PM patients with PCI \>6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
21 Years
99 Years
ALL
No
Sponsors
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National Cancer Centre, Singapore
OTHER
Responsible Party
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Principal Investigators
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Claramae Chia, MBBS
Role: PRINCIPAL_INVESTIGATOR
National Cancer Centre, Singapore
Locations
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National Cancer Center Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Other Identifiers
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PIPAC
Identifier Type: -
Identifier Source: org_study_id
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