Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
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- STATUS
- Recruiting
-
- End date
- Oct 1, 2027
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- participants needed
- 40
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- sponsor
- National Cancer Institute (NCI)
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 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 might 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 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.
Description
- Background
An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the 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 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.
Details
| Condition | Gastric Adenocarcinoma, Esophagogastric Junction, Gastric Cancer |
|---|---|
| Treatment | cisplatin, Surgery, Sodium Thiosulfate, Mitomycin C |
| Clinical Study Identifier | NCT03092518 |
| Sponsor | National Cancer Institute (NCI) |
| Last Modified on | 21 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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