PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Public ClinicalTrials.gov record NCT04329494. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial studies the side effects of pressurized intraperitoneal aerosol chemotherapy (PIPAC) in treating patients with ovarian, uterine, appendiceal, stomach (gastric), or colorectal cancer that has spread to the lining of the abdominal cavity (peritoneal carcinomatosis). Chemotherapy drugs, such as cisplatin, doxorubicin, oxaliplatin, leucovorin, fluorouracil, mitomycin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PIPAC is a minimally invasive procedure that involves the administration of intraperitoneal chemotherapy. The study device consists of a nebulizer (a device that turns liquids into a fine mist), which is connected to a high-pressure injector, and inserted into the abdomen (part of the body that contains the digestive organs) during a laparoscopic procedure (a surgery using small incisions to introduce air and to insert a camera and other instruments in the abdominal cavity for diagnosis and/or to perform routine surgical procedures). Pressurization of the liquid chemotherapy through the study device results in aerosolization (a fine mist or spray) of the chemotherapy intra-abdominally (into the abdomen). Giving chemotherapy through PIPAC may reduce the amount of chemotherapy needed to achieve acceptable drug concentration, and therefore potentially reduces side effects and toxicities.
Study identification
- NCT ID
- NCT04329494
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 49 participants
Conditions and interventions
Conditions
- Clinical Stage IV Gastric Cancer AJCC v8
- Clinical Stage IVA Gastric Cancer AJCC v8
- Clinical Stage IVB Gastric Cancer AJCC v8
- Malignant Uterine Neoplasm
- Metastatic Appendix Carcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Gastric Carcinoma
- Metastatic Malignant Neoplasm in the Peritoneum
- Metastatic Malignant Solid Neoplasm
- Metastatic Ovarian Carcinoma
- Pathologic Stage IV Gastric Cancer AJCC v8
- Peritoneal Carcinomatosis
- Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
- Stage IV Appendix Carcinoma AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Uterine Corpus Cancer AJCC v8
- Stage IVA Appendix Carcinoma AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Uterine Corpus Cancer AJCC v8
- Stage IVB Appendix Carcinoma AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Uterine Corpus Cancer AJCC v8
- Stage IVC Appendix Carcinoma AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
Interventions
- Biopsy Procedure
- Cisplatin Drug
- Doxorubicin Drug
- Fluorouracil Drug
- Intraperitoneal Chemotherapy Device
- Irinotecan Drug
- Leucovorin Drug
- Mitomycin Drug
- Oxaliplatin Drug
- Quality-of-Life Assessment Other
- Questionnaire Administration Other
Procedure · Drug · Device + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 20, 2020
- Primary completion
- Jan 4, 2028
- Completion
- Jan 4, 2028
- Last update posted
- Aug 25, 2026
2020 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Active, not recruiting |
| Northwell Health Cancer Institute at Huntington | Greenlawn | New York | 11740 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04329494, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04329494 live on ClinicalTrials.gov.