PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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 measures
- 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]
Secondary outcome measures (1)
- To study recurrence pattern in patients with recurrence during the study period [Time frame: From enrollment up to 60 months]
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:
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 60,000/Ul
- Serum creatinine <= 1.5 mg/dL 5)Distant metastatic disease of peritoneum may be visualized on imaging:
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- Positive peritoneal cytology only
- Carcinomatosis on diagnostic laparoscopy or laparotomy.
Exclusion criteria
- 1)Distant metastatic disease not limited to peritoneum:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Banner MD Anderson Cancer Center — Gilbert
Identifiers
NCT: NCT07178808 · 1480-262