PHASE II EVALUATION OF CYTOREDUCTION SURGERY AND HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (CRS/HIPEC) IN GASTRIC CANCER
Recruiting
Phase 2Interventional Study
Gastric Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Banner Health · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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 marr…
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.
Contacts
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