About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 60,000/Ul
Disqualifiers
Solid organ metastases (liver, central nervous system, lung). 2) Infections such as pneumonia or wound infections that would preclude protocol therapy.
Trial design
Single group
Treatments tested in this trial
Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Procedure/SurgeryCRS/HIPEC involves aggressive surgical cytoreduction of all visible and palpable tumors, followed by the synergistic use of heated and high dose chemotherapy to address microscopic residual disease.
Treatment groups
Trial outcomes
Primary outcomes
To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
To determine if preoperative laparoscopic HIPEC and chemotherapy followed by cytoreductive surgery (CRS), gastrectomy and HIPEC in patients with peritoneal surface-only metastasis will improve PFS and/or OS from date of diagnosis of metastatic gastric adenocarcinoma
Secondary outcomes
To study recurrence pattern in patients with recurrence during the study period
Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging.
Sponsors and contacts
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