Peritoneal carcinomatosis of gastric origin Stomach Cancer with metastasis in the peritoneum
Conditions
Interventions
Patients are first discussed in a multi-disciplinary tumor board for
eligibility for this study, that is macroscopic peritoneal metastases and no
other regular treatment options available. Patients
one prior to therapy initiation and one
after completion of the 6 cycles
these scans will be used to evaluate
peritoneal response.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 45 and Creatinine clearance
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to establish the maximum tolerable dose and recommended phase II dose of intraperitoneal irinotecan added to systemic chemotherapy (capecitabine/oxaliplatin) in patients with peritoneal metastasis of gastric origin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are to explore the safety and feasibility of this treatment and to establish the pharmacokinetic profile of intraperitoneal administered irinotecan. During this study we will also collect and store ascites for (future) translational research purposes and we will investigate the value of the 68Ga-FAPI PET/CT for peritoneal response evaluation. | — |
Countries
Netherlands
Outcome results
None listed