CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 49 target
Drug / intervention
Cisplatin +10 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Histologically confirmed ovarian, uterine, gastric, appendiceal or colorectal cancer with peritoneal carcinomatosis
  • Peritoneal disease visible on cross-sectional imaging or diagnostic laparoscopy
  • Prior intraperitoneal chemotherapy is permitted
  • Documented informed consent
Key exclusion· 25
  • Gastric and colorectal/appendiceal: extra-peritoneal metastatic disease
  • Arm 1: Prior treatment with maximum cumulative doses of anthracyclines and anthracenediones
  • Arm 2/3: Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Arm 2/3: Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or exclusive total parenteral nutrition

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04329494
NCT04329494Phase 1RecruitingOn TrackUpdated 6mo ago
Long Recruiting

Safety and Efficacy of Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Ovarian, Uterine, Appendiceal, Colorectal, and Gastric Cancer Patients With Peritoneal Carcinomatosis (PC)

City of Hope Medical Center·interventional·Posted Apr 1, 2020·Updated Dec 10, 2025

In Brief

A Phase 1 clinical trial evaluating Biopsy, Cisplatin, and 9 other interventions for Clinical Stage IV Gastric Cancer AJCC v8 and 26 related conditions. Currently recruiting, targeting 49 participants across 3 sites.

Detailed Summary

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 Details

Timeline

Phase 1Recruiting
20212022202320242025202620272028
First PostedApr 1, 2020
Enrollment StartAug 21, 2020
Primary CompletionJan 5, 2028
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 6.3 years agoPrimary completion in 1.5 years

Interventions

Biopsyprocedure

Undergo biopsy

Cisplatindrug

Given via PIPAC

Doxorubicindrug

Given via PIPAC

Fluorouracildrug

Given IV

Intraperitoneal Chemotherapydevice

Undergo PIPAC

Irinotecandrug

Given IV

Leucovorindrug

Given IV

Mitomycindrug

Given via PIPAC

Oxaliplatindrug

Given via PIPAC

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies