Status:
COMPLETED
Adjuvant PIPAC in Gastric Cancer Patients
Lead Sponsor:
Michael Bau Mortensen
Conditions:
Gastric Adenocarcinoma
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 commercial...
Detailed Description
Gastric adenocarcinoma (GAC) is considered the fifth most common cancer in the word and the third leading cause of cancer death globally. The majority of GAC patients presents with advanced stages of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04047004
Start Date
March 11 2020
End Date
October 1 2022
Last Update
October 6 2022
Active Locations (2)
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1
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense, Denmark, 5000
2
Karolinska University Hospital
Stockholm, Sweden