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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy | Experimental | Patients will undergo cytoreduction & hyperthermic intraperitoneal chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess improvements in survival in gastric adenocarcinoma patients with occult or apparent carcinomatosis after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy | 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 | From enrollment up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| To study recurrence pattern in patients with recurrence during the study period | Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. | From enrollment up to 60 months |
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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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States |
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| ID | Term |
|---|---|
| D065426 | Cytoreduction Surgical Procedures |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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