Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2018-10-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loma Linda University

Criteria

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