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NCT04329494 · ClinicalTrials.gov registry record · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 3
- Study locations
NCT04329494 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 49 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (76% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04329494, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Cisplatin
- PROCEDURE Biopsy
- DRUG Doxorubicin
- DRUG Fluorouracil
- DEVICE Intraperitoneal Chemotherapy
Study Locations (3)
California
- City of Hope Medical Center - Duarte
Florida
- Mayo Clinic in Florida - Jacksonville
New York
- Northwell Health Cancer Institute at Huntington - Greenlawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2028-01-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04329494
The ClinicalTrials.gov registry entry for NCT04329494 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (76% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT04329494 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04329494 about?
NCT04329494 is a clinical study titled "PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer". 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 dru...
What is the current status of trial NCT04329494?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2020-08-21. Estimated completion is 2028-01-05.
What conditions does trial NCT04329494 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Colorectal Carcinoma, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT04329494?
The interventions under investigation include: Cisplatin (DRUG), Biopsy (PROCEDURE), Doxorubicin (DRUG), Fluorouracil (DRUG), Intraperitoneal Chemotherapy (DEVICE).
Who is sponsoring clinical trial NCT04329494?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04329494 being conducted?
This trial has 3 study locations across California, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.