Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carci… (NCT05379790) | Clinical Trial Compass
CompletedPhase 1
Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin
Netherlands20 participantsStarted 2022-05-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the maximum-tolerated dose of combining intraperitoneal and systemic chemotherapy, what does that mean for what we currently know — or don't know — about whether this approach is safe or effective for my specific situation?
2This trial has already completed recruitment, so no new patients can enroll — but are the safety and dosing results available yet, and could those findings change any treatment options you'd recommend for me?
3Because this trial targets extensive peritoneal metastases from gastric cancer, how does my current extent of peritoneal spread compare to what was studied here, and does that affect whether insights from this trial are relevant to my care?
4Intraperitoneal chemotherapy involves delivering drugs directly into the abdominal cavity alongside systemic treatment — what kinds of side effects or risks were associated with that combination in trials like this one, and how would those compare to what I'd face with standard treatment?
5Before considering an approach like this, would you recommend trying standard systemic chemotherapy first, and what would help us decide if a more aggressive combined strategy might be worth discussing down the road?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.