Locally Advanced Malignant Neoplasm, Gastric Cancer
Conditions
Brief summary
The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.
Detailed description
Treatment Plan: Patients undergoing definitive resection for gastric cancer and meeting the eligibility criteria will be treated with HIPEC using a single dose of Mitomycin 15mg/m2 and Cisplatin 50mg/m2 at 41-42 C for 90 minutes. HIPEC will be performed after resection but before anastomosis. Both Cisplatin and Mitomycin are commercially available chemotherapeutic agents and will be obtained as marketed drugs. Outcome Measures: Patients will be followed for 90 days following surgery. All postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification. Schedule for Follow Up: Trial-related patient assessments will be performed daily while the patient remains in the hospital for postoperative care, and then during postoperative clinic visits. The final postoperative clinic visit for evaluation of study outcomes and complications should occur between postoperative days 90 and 95 to allow for a cumulative assessment of the patient's perioperative complications, if any.
Interventions
Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18-75 with biopsy-proven gastric adenocarcinoma 2. Tumor clinically staged T3 or T4 and/or nodes staged clinically positive 3. ECOG performance status \< 2
Exclusion criteria
1. Distant metastases 2. Peritoneal carcinomatosis 3. Synchronous malignancy 4. Tumors at the gastroesophageal junction 5. Recurrent gastric adenocarcinoma 6. Creatinine \>/= 1.5 7. Bilirubin \>/= 2 8. INR \>/= 2 9. Allergy to drugs included in the treatment plan 10. Pregnancy 11. Contraindication to major surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Complications | 90 days following surgery | Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification. |
Countries
United States
Outcome results
None listed