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

Not Applicable

Recruiting

• Conditions: Gastric Adenocarcinoma

• Registration Number: NCT07178808
• Lead Sponsor: Banner Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-16
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Primary Completion: 2026-02-22
• Study Completion: 2031-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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:
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  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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy	From enrollment up to 60 months	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 Outcome Measures

Name	Time	Method
To study recurrence pattern in patients with recurrence during the study period	From enrollment up to 60 months	Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging.

Trial Locations

Locations (1)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States