PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY
This is a Phase II treatment study analyzing the role of preoperative chemotherapy, preoperative laparoscopic HIPEC, and gastrectomy with CRS/HIPEC in gastric adenocarcinoma patients with cytology-positive only carcinomatosis, radiologically-occult carcinomatosis, or radiology apparent peritoneal-surface only metastati
| Condition(s) | Gastric Adenocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a Phase II treatment study analyzing the role of preoperative chemotherapy, preoperative laparoscopic HIPEC, and gastrectomy with CRS/HIPEC in gastric adenocarcinoma patients with cytology-positive only carcinomatosis, radiologically-occult carcinomatosis, or radiology apparent peritoneal-surface only metastatic disease. |
| Who can participate | Inclusion Criteria: * 1\) Age 18 years and above. There will be no upper age restriction. 2)ECOG performance status ≤ 2. (See Appendix A -ECOG Performance Status Scale). 3)Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction. 4)Adequate renal, and bone marrow function: 1. Leukocytes \>= 3,000/uL 2. Absolute neutrophil count \>= 1,500/uL 3. Platelets \>= 60,000/Ul 4. Serum creatinine \<= 1.5 mg/dL 5)Distant metastatic disease of peritoneum may be visualized on imaging: <!-- --> 1. Positive peritoneal cytology only 2. Carcinomatosis on diagnostic laparoscopy or laparotomy. Exclusion Criteria: * 1)Distant metastatic disease not limited to peritoneum: 1. Solid organ metastases (liver, central nervous system, lung). 2) Infections such as pneumonia or wound |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Banner Health |
| Locations | Gilbert, Arizona, United States |
| Start date | 2021-04-16 |
| NCT ID | NCT07178808 |
| Official listing | https://clinicaltrials.gov/study/NCT07178808 |