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NCT03092518 · ClinicalTrials.gov registry record · Phase 2
Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT03092518: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03092518 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03092518, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Background: \- Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs. Researchers want to see if a new treatment helps. It is surgical removal of the cancer and heated chemotherapy delivered to the abdominal cavity called Hyperthermic intraperitoneal chemotherapy (HIPEC). Objective: \- To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve survival in people with gastric cancers. Eligibility: \- People ages 18 and older with gastric cancer who can have most tumors surgically removed Design: * Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Scans * Tissue sample from previous surgery * Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach. It and takes a sample of stomach tissue. Participants may get medicine to make them drowsy. * Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is inserted into the abdomen. Participants sleep through the procedure. Participants will stay in the hospital. They will have: * Surgery to remove as many tumors as possible. * HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs are given through one tube. They are drained out through another at a temperature a few degrees above normal body temperature. Another drug is given in a vein. * Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and intravenous (IVs) for a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as needed. * Participants will have visits every few months for 3 years, then one a year. Visits include physical exam, blood tests, and scans. They also include dietary assessment and questions.
Primary Outcome
OS is defined as the median amount of time a participant survives after therapy.
Interventions
- DRUG Cisplatin
- PROCEDURE Surgery
- DRUG Mitomycin C
- PROCEDURE Tumor Biopsy
- DRUG Sodium Thiosulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2024-07-24 |
| Phase | Phase 2 |
What the finished NCT03092518 record still lists
NCT03092518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT03092518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03092518 about?
NCT03092518 is a clinical study titled "Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology". Background: \- Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs. Researchers want to see if a new treatment helps. It is surgical removal of the cancer and heated chemotherapy delivered to the abdominal cavity called Hyperthermic intraperitoneal chemotherapy (...
What is the current status of trial NCT03092518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2017-06-05. Estimated completion is 2024-07-24.
What interventions are being tested in trial NCT03092518?
The interventions under investigation include: Cisplatin (DRUG), Surgery (PROCEDURE), Mitomycin C (DRUG), Tumor Biopsy (PROCEDURE), Sodium Thiosulfate (DRUG).
Who is sponsoring clinical trial NCT03092518?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03092518's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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