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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: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome.
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 |
What NCT04329494 shows while recruiting
NCT04329494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (76% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Metastatic Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04329494's enrollment target sits among peer trials
49 56th of 92 higher than 37 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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