Recruiting
Phase 2

Chemotherapy, HIPEC, Gastrectomy

Sponsor:

Banner Health

Code:

NCT07178808

Conditions

Gastric Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Study Details

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.

Conditions

Gastric Adenocarcinoma

Study ID

NCT07178808

Start date

Apr 16, 2021

Status verified date

Sep, 2025

Completion date

Feb 22, 2031

Anticipated

Primary completion date

Feb 22, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Patients will undergo cytoreduction \& hyperthermic intraperitoneal chemotherapy

Interventions

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

CRS/HIPEC involves aggressive surgical cytoreduction of all visible and palpable tumors, followed by the synergistic use of heated and high dose chemotherapy to address microscopic residual disease.

Primary outcome measure

  • To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy [ Time Frame: From enrollment up to 60 months ]

Central Contacts and Locations

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Rajesh Ramanathan

More Information

Sponsor

Banner Health

Last update posted

May 1, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Banner Health on 2026-05-01.