Using pressurized chemotherapy for peritoneal metastases
Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastases
This study is testing a new way to deliver chemotherapy directly into the abdomen for patients with advanced cancers that have spread there, to see if it helps relieve symptoms and is safe to use.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National Cancer Centre, Singapore Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04956068 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for patients with peritoneal metastases from gastrointestinal and other rare cancers. PIPAC is a novel method that delivers chemotherapy directly into the peritoneal cavity, enhancing drug distribution and uptake while minimizing invasiveness. The trial focuses on patients who are not candidates for curative surgery and aims to alleviate local symptoms associated with extensive peritoneal metastases. Participants will undergo treatment to assess the effectiveness and safety of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with unresectable peritoneal metastases from gastrointestinal, hepatopancreatobiliary, or other rare cancers who are fit for systemic chemotherapy.
Not a fit: Patients with resectable peritoneal metastases or those who are not fit for chemotherapy or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant symptom relief and improved quality of life for patients with peritoneal metastases.
How similar studies have performed: Other studies using similar intraperitoneal chemotherapy techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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: * 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 undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
Where this trial is running
Singapore
- National Cancer Center Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Claramae Chia, MBBS — National Cancer Centre, Singapore
- Study coordinator: Claramae Chia, MBBS
- Email: claramae.chia.s.l@singhealth.com.sg
- Phone: +65 6436 8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.