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NCT04847063 · ClinicalTrials.gov registry record · Phase 1
Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies
A Phase 1 study of Ovarian Cancer and Gastrointestinal Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04847063: Recruiting Phase 1 study of Ovarian Cancer and Gastrointestinal Cancer, sponsored by National Cancer Institute (NCI).
NCT04847063 is a Phase 1 study of Ovarian Cancer and Gastrointestinal Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04847063, a Phase 1 study of Ovarian Cancer and Gastrointestinal Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy drugs used in HIPEC. Objective: To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System. Eligibility: Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Computed tomography (CAT) scan Other imaging scans, as needed Electrocardiogram (EKG) Tumor biopsy, if needed Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera will be used to see their organs. Some screening tests will be repeated in the study. Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research. Participants will have CRS. As many of their visible tumors will be removed as possible. They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get chemotherapy through one tube. It will be drained out through the other tube. They will be in the hospital for 7-21 days after surgery. Participants will give tumor, blood, and fluid samples for research. They will complete surveys about their health and quality of life. Participants will have follow-up visits over 5 years.
Primary Outcome
percent necrosis and Ki-67 scores will be obtained and used to determine the correlation between each measure by ex vivo simulated HIPEC in the SMART System or 3-D cell culture (organoid) models, and by in vivo intra-operative HIPEC
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Doxorubicin
- DRUG Oxaliplatin
- DRUG Mitomycin C
- PROCEDURE Heated Intraperitonial Chemotherapy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2031-12-30 |
| Phase | Phase 1 |
What NCT04847063 shows while recruiting
NCT04847063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT04847063 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04847063 about?
NCT04847063 is a clinical study titled "Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies". Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can im...
What is the current status of trial NCT04847063?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-10-19. Estimated completion is 2031-12-30.
What conditions does trial NCT04847063 study?
This clinical trial studies the following conditions: Ovarian Cancer, Gastrointestinal Cancer, Peritoneal Carcinomatosis, Appendiceal Cancer, Peritoneal Mesothelioma.
What interventions are being tested in trial NCT04847063?
The interventions under investigation include: Cisplatin (DRUG), Doxorubicin (DRUG), Oxaliplatin (DRUG), Mitomycin C (DRUG), Heated Intraperitonial Chemotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT04847063?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04847063 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04847063's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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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