Gastric Adenocarcinoma
Conditions
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.
Interventions
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.
Sponsors
Banner Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy | From enrollment up to 60 months | To determine if preoperative laparoscopic HIPEC and chemotherapy followed by cytoreductive surgery (CRS), gastrectomy and HIPEC in patients with peritoneal surface-only metastasis will improve PFS and/or OS from date of diagnosis of metastatic gastric adenocarcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To study recurrence pattern in patients with recurrence during the study period | From enrollment up to 60 months | Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. |
Countries
United States
Outcome results
None listed