Overview
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
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:
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 60,000/Ul
- Serum creatinine <= 1.5 mg/dL 5)Distant metastatic disease of peritoneum may be visualized on imaging:
- Positive peritoneal cytology only
- Carcinomatosis on diagnostic laparoscopy or laparotomy.
Exclusion Criteria:
- 1)Distant metastatic disease not limited to peritoneum:
- Solid organ metastases (liver, central nervous system, lung). 2) Infections such as pneumonia or wound infections that would preclude protocol therapy.
- Women with a positive urine or serum pregnancy test are excluded from this
study; women ofchildbearing potential (defined as those who have not undergone
a hysterectomy or who have not been postmenopausal for at least 24 consecutive
months) must agree to refrain from breast feeding and practice adequate
contraception as specified in the informed consent. Adequate contraception
consists of oral contraceptive, implantable contraceptives, injectable
contraceptives, a double barrier method, or abstinence.
4)Participants with unstable angina or New York Heart Association Grade II or greater congestive heart failure.
- Participants deemed unable to comply with study and/or follow-up procedures. 6)Participants with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.