Cytoreductive surgery plus heated intraperitoneal chemotherapy for gastric cancer with peritoneal-only spread

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

This study will try cytoreductive surgery combined with heated intraperitoneal chemotherapy, together with preoperative chemotherapy and laparoscopic HIPEC, in adults whose gastric adenocarcinoma is limited to the peritoneum or shows positive peritoneal cytology.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Banner Health (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Gilbert, Arizona)
• Trial ID: NCT07178808 on ClinicalTrials.gov

What this trial studies

This Phase II interventional trial tests a multimodal approach combining preoperative systemic chemotherapy, a diagnostic laparoscopic HIPEC procedure, and gastrectomy with cytoreductive surgery (CRS) followed by intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with gastric adenocarcinoma confined to the peritoneal surfaces or with positive peritoneal cytology. Eligible patients are adults with pathologic confirmation of gastric or gastroesophageal junction adenocarcinoma, ECOG performance status ≤2, adequate bone marrow and renal function, and no distant solid organ metastases. The protocol enrolls patients whose peritoneal disease is either only cytology-positive, radiologically occult but found at laparoscopy, or radiologically apparent but limited to peritoneal surfaces. Outcomes will focus on feasibility, safety, and oncologic outcomes after CRS/HIPEC in this selected population.

Who should consider this trial

Good fit: Adults (≥18) with histologic or cytologic gastric adenocarcinoma limited to the peritoneum (including positive peritoneal cytology), who have ECOG ≤2 and adequate blood and kidney function and who are fit for major surgery, are the intended candidates.

Not a fit: Patients with distant solid organ metastases (liver, lung, brain), active infections that preclude surgery, poor performance status, or pregnancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve local disease control and meaningfully extend survival for selected patients with peritoneal-only spread of gastric cancer.

How similar studies have performed: Single-center series and nonrandomized reports have shown prolonged survival for selected patients after CRS/HIPEC, but randomized evidence is limited and results across studies have been mixed.

Eligibility 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:

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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.

Where this trial is running

Gilbert, Arizona

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)

Conditions Gastric Adenocarcinoma