Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03092518
Brief 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.
Detailed Description:
Background:
* An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.).
* The peritoneal surface is a site of metastasis found often at time of diagnosis and is a common (40%) site of recurrence.
* Laparoscopy with peritoneal lavage and cytopathologic analysis is a staging modality that can identify a subset of patients with microscopic peritoneal metastasis prior to consideration for definitive surgical therapy.
* Intraperitoneal chemotherapy has been employed in advanced gastric cancers and as an adjuvant with an associated improvement in survival in systematic reviews.
Objectives:
\- Determine the overall survival in patients with cytology-positive gastric cancer treated with Hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy.
Eligibility:
* Histologically confirmed adenocarcinoma of the stomach.
* Cytopathologic evidence of peritoneal carcinomatosis.
* Medically fit for systemic chemotherapy, HIPEC and gastrectomy.
Design:
\- Single arm, Phase II study of HIPEC and gastrectomy.
Study:
NCT03092518
Study Brief:
Protocol Section:
NCT03092518