Adjuvant PIPAC in Gastric Cancer Patients

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study patients will be offered intraperitoneal atomized chemotherapy as a supplement to the standard treatment of high-risk gastric cancer (laparoscopic removal of the stomach). Two commercially available oncologic drugs will be used (doxorubicin and cisplatin).

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

Details

• Lead Sponsor: Michael Bau Mortensen
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Patients with high-risk GAC defined as: Diffuse cancer (signet ring cells predominant) or clinical stage: cTany + cN2-3 or cT3-T4 + cNany or GAC patients with preoperative positive peritoneal cytology submitted to laparoscopic gastrectomy (+/- neoadjuvant treatment).

• Age 18 or above

• Written informed consent

• Women must be postmenopausal or use adequate contraception with a negative pregnancy test at inclusion.

Exclusion Criteria:

• Previous allergic reaction to cisplatin, doxorubicin or other platinum containing compounds.

• Renal impairment, defined as GFR < 40 ml/min (Cockcroft-Gault Equation).

• Myocardial insufficiency, defined as NYHA class 3-4.

• Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).

• Inadequate haematological function defined as absolute neutrophil count (ANC) ≤ 1.5 x 10^9/l and platelets ≤ 100 x 10^9/l.

• Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.