Phase
Condition
Neoplasm Metastasis
Treatment
PIPAC
Clinical Study ID
Ages 21-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For Unesectable PM Group:
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 withoxaliplatin; e-GFR > 60mls/min for patients undergoing PIPAC withDoxorubicine/Cisplatin)
Adequate liver function (Total bilirubin < 1.5 upper limit of normal; ALT and AST< 3upper 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 withdoxorubicin/ cisplatin)
Histological/ cytological proof of PM from GI, HPB, Gynaecology, Breast, Sarcomaprimaries
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 intraperitonealchemotherapy (HIPEC) surgery after diagnostic laproscopy - PCI > 18 in LGI, PCI > 6in UGI ECOG < 3
In UGI PM patients, progression while on bidirectional chemotherapy
Exclusion
Exclusion Criteria:
Patient is medically unfit for surgery due to concurrent medical comorbidities,including but not limited to intestinal obstruction, multiple sites of metastases
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 undergostandard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
Study Design
Connect with a study center
National Cancer Center Singapore
Singapore, 169690
SingaporeActive - Recruiting
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