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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03092518
The ClinicalTrials.gov registry entry for NCT03092518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT03092518 reports 0 study locations.
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.
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