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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.