NCT05379790CompletedPhase 1
Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously. Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 25 Apr 2022
- Start date
- 25 May 2022
- Primary completion date
- 25 Nov 2024
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05379790
- EU CT number
- 2024-516265-37-00
- EudraCT number
- 2021-005907-11
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 25 May 2022 to the primary completion date, 25 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant disease or active infections.
- 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.
- Concomitant participation in a competing clinical study.
Other illness
- 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.
- 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.
Other
- Medical or psychological impediment to probable compliance with the protocol.
- 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.
- Homozygous UGT1A1\*28 genotype.
- Homozygous dihydropyrimidine dehydrogenase (DPYD) genotype (tested for \*2A, \*13, 2846A\>T, and 1236G\>A).
- Pregnant or lactating women.
- Absence of assurance of compliance with the protocol.
Who the study is looking for
- Patients with a histologically confirmed diagnosis of HER2-negative gastric cancer.
- A histologically confirmed diagnosis of peritoneal carcinomatosis.
- Age ≥ 18 years old.
- Written informed consent according to the ICH-GCP and national/local regulations.
- A peritoneal cancer index (PCI) ≥7 evaluated by laparoscopy or laparotomy before inclusion in this trial.
- Patients must be ambulatory: World Health Organisation (WHO) performance status 0 or 1.
- Life expectancy of at least 3 months.
- Ability to return to the Erasmus MC 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:
- absolute neutrophil count \>1.5 \* 10\^9/l;
- platelet count \>100\*10\^9/l;
- Hb\>6.0mmol/l;
- Bilirubin \< 1.5x upper limit of normal (ULN);
- Serum aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2.5 x ULN;
- Glomerular Filtration Rate (GFR) \>45 and Creatinine clearance \<2 x ULN.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.