Adjuvant Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Gastric Cancer

Completed · Phase 1

Conditions studied: Locally Advanced Malignant Neoplasm, Gastric Cancer

In brief

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.

Key facts

Study ID

NCT02672865

Run by

Loma Linda University

People needed

4

Starts

2016-02-02

Expected to finish

2018-10-03

Last updated by the study team

2019-04-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
• Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
• ECOG performance status < 2

You may not qualify if…

• Distant metastases
• Peritoneal carcinomatosis
• Synchronous malignancy
• Tumors at the gastroesophageal junction
• Recurrent gastric adenocarcinoma
• Creatinine >/= 1.5
• Bilirubin >/= 2
• INR >/= 2
• Allergy to drugs included in the treatment plan
• Pregnancy
• Contraindication to major surgery

Where it is running

• Loma Linda University Cancer Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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