Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
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|ClinicalTrials.gov Identifier: NCT03092518|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : October 21, 2019
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.
To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve survival in people with gastric cancers.
People ages 18 and older with gastric cancer who can have most tumors surgically removed
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Esophagogastric Junction Gastric Cancer||Procedure: Surgery Drug: Cisplatin Drug: Mitomycin C Drug: Sodium Thiosulfate||Phase 2|
- 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
- Determine the overall survival in patients with cytology-positive gastric cancer treated with HIPEC and gastrectomy
- Histologically confirmed adenocarcinoma of the stomach
- Cytopathologic evidence of peritoneal carcinomatosis
- Medically fit for systemic chemotherapy, HIPEC and gastrectomy
- Single arm, phase II study of HIPEC and gastrectomy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology|
|Actual Study Start Date :||June 5, 2017|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2020|
Experimental: 1/Arm 1
HIPEC with gastrectomy
Heated Intraperitonial Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitocycin C and sodium thiosulfate
Cisplatin (90mg/m2) will be administered via circuit to the peritoneal cavity.
Drug: Mitomycin C
Mytomycin C 10mg/m2 will be administered via circuit to the peritoneal cavity
Drug: Sodium Thiosulfate
Sodium Thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours.
- Overall survival [ Time Frame: death ]median amount of time subject survives after therapy
- intraperitoneal progression free survival [ Time Frame: at intraperitoneal progression ]median amount of time subject survives without intraperitoneal disease progression after treatment
- extra-peritoneal disease free survival [ Time Frame: at extraperitoneal progression ]median amount of time subject survives without extraperitoneal disease progression after treatment
- morbidity [ Time Frame: 5 years ]list of adverse event frequency
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092518
|Contact: NIH Foregut Team||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jeremy L Davis, M.D.||National Cancer Institute (NCI)|