Concomitant intraperitoneal and systemic chemotherapy in patients with extensive peritoneal carcinomatosis of gastric origi
- Conditions
- Peritoneal carcinomatosis of gastric originStomach Cancer with metastasis in the peritoneum100346521002747610017998
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
• Patients with a histologically confirmed diagnosis of HER2-negative gastric
cancer.
• A histologically confirmed diagnosis of macroscopic peritoneal carcinomatosis
(PCI >=1).
• Age >= 18 years old.
• Written informed consent according to the ICH-GCP and national/local
regulations.
• Patients must be ambulatory: WHO performance status 0 or 1 (Appendix A,
protocol).
• Life expectancy of at least 3 months.
• Ability to return to the Erasmus MC or Catharina Hospital for adequate
follow-up as required by this protocol.
• Patients must have normal organ function and adequate bone marrow reserve as
assessed by the following laboratory requirements:
o absolute neutrophil count >1.5 * 10^9/l;
o platelet count >100*10^9/l;
o Hb>6.0mmol/l;
o Bilirubin < 1.5x upper limit of normal (ULN);
o Serum AST and ALT < 2.5 x ULN;
o GFR>45 and Creatinine clearance <2 x ULN.
• Medical or psychological impediment to probable compliance with the protocol.
• Serious concomitant disease or active infections.
• Distant metastasis other than peritoneal metastasis or metastatic lymph
nodes.
• No sufficient oral food intake.
• Polyneuropathy grade 2 or worse according to CTCAE version 5.0.
• History of auto-immune disease or organ allografts, or with active or chronic
infection, including HIV and viral hepatitis.
• Serious intercurrent chronic or acute illness such as pulmonary (COPD or
asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness
considered by the study coordinator to constitute an unwarranted high risk for
participation in this study.
• Homozygous UGT1A1*28 genotype.
• Homozygous DPYD genotype (tested for *2A, *13, 2846A>T, and 1236G>A).
• Current use of strong CYP3A4-inhibitors or inducers. If patients use this
CYP3A4-modulating medication, it is allowed to stop it within 14 days of start
of treatment.
• Pregnant or lactating women.
• Concomitant participation in a competing clinical study.
• Absence of assurance of compliance with the protocol.
• An organic brain syndrome or other significant psychiatric abnormality which
would comprise the ability to give informed consent, and preclude participation
in the full protocol and follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The aim of this study is to establish the maximum tolerable dose and<br /><br>recommended phase II dose of intraperitoneal irinotecan added to systemic<br /><br>chemotherapy (capecitabine/oxaliplatin) in patients with peritoneal metastasis<br /><br>of gastric origin. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are to explore the safety and feasibility of this treatment<br /><br>and to establish the pharmacokinetic profile of intraperitoneal administered<br /><br>irinotecan. During this study we will also collect and store ascites for<br /><br>(future) translational research purposes and we will investigate the value of<br /><br>the 68Ga-FAPI PET/CT for peritoneal response evaluation. </p><br>