Laparoscopic HIPEC with Chemoradiation as First Line Treatment in Treating Patients with Local Regional Advanced Gastric Cancer

Inclusion Criteria

• Clinical diagnosis of gastric cancer post endoscopic ultrasound (EUS), staging must be T3/T4
• N0/+, M0. EUS must have been done within 8 weeks of the protocol start (diagnostic laparoscopy)
• Patient must plan to undergo surgical treatment
• Performance status - Eastern Cooperative Oncology Group (ECOG) scale of performance status of 0-2
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcl
• Total bilirubin >= 1.5 mg/dl (Gilbert’s syndrome, then < 3.0)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits (< 1.5 x ULN)
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Recommended methods of birth control are: The consistent use of an approved hormonal contraception (birth control pill/patches, rings), an intrauterine device (IUD), contraceptive injection (Depo-Provera), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse) or sterilization. Some study drugs interact with hormonal contraceptives and make them less effective or they should not be used with the disease/condition under study. If that is the case, delete the hormonal methods listed above and state why they are not recommended while taking part in the study. Men must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Subjects who have any previous treatment for their cancer
• Patients with known metastatic disease will be excluded from this study; this includes patients with clinically apparent or suspected metastasis to sites other than lymph nodes or peritoneal surfaces
• Subjects with early stage gastric cancer (stage T1/T2 N0)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents being used in this study, including but not limited to: carboplatin, taxol, fluorouracil (5-FU), leucovorin, mitomycin C
• Subjects who have received prior radiation to any portion of the abdominal cavity or pelvis are excluded
• Subjects who have had prior malignancies, except for cured non-melanoma skin cancer, or curatively treated in situ carcinoma of the cervix, or adequately treated malignancies for which there has been no evidence of activity for more than 3 years
• Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• Subjects with a condition that may interfere with the subjects’ ability to understand the requirements of the study
• Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C positive patients
• Patients with active coronary artery disease (defined as unstable angina or a positive cardiac stress test) will be excluded. Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment
• Patients with restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded
• Patients with a history of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study will be excluded
• Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study, will also be excluded
• Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon
• Patients with any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy
• Patients with a life expectancy of less than 12 weeks will be excluded from this study