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NCT07178808 | RECRUITING | Gastric Adenocarcinoma

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

Condition or disease

Gastric Adenocarcinoma

Intervention/treatment

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER
Actual Study Start Date : 2021-04-16
Estimated Primary Completion Date : 2026-02-22
Estimated Study Completion Date : 2031-02-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER

Location Details

NCT07178808

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How to Participate

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Locations

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, arizona, United States, 85234