PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER

Banner Health

Status and phase

Enrolling

Phase 2

Conditions

Gastric Adenocarcinoma

Treatments

Procedure: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07178808

1480-262

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 infections that would preclude protocol therapy.
  
  3) 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.
  
  5) 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.