Actively Recruiting
Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis
Led by Magnus Nilsson · Updated on 2025-12-26
262
Participants Needed
5
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.
CONDITIONS
Official Title
Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
- Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
- Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment
- Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy
- Adequate hematology assessment and serum chemistry
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age of at least 18 years
- Life expectancy of at least three months
- Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable
You will not qualify if you...
- Comorbidity that does not allow treatment with standard systemic therapy or intraperitoneal paclitaxel
- Confirmed or suspected severe abdominal adhesions
- Severe coagulation disorder which precludes surgical interventions
- Distant metastases other than peritoneal, except ovarian metastases
- Symptomatic ascites requiring or expected to require drainage soon
- Peritoneal recurrence of gastric cancer within 6 months after curative surgery
- More than 2 cycles of palliative systemic chemotherapy received for current gastric cancer (except cytology positive patients without manifest peritoneal metastases); perioperative chemotherapy allowed
- Another malignancy affecting survival within 3 years
- Known or suspected allergies to any trial intervention products
- DYPD deficiency
- Pregnancy, recent delivery within 28 days postpartum, or ongoing breastfeeding
- Active sex-life without use of secure contraceptive method
- Investigator decision that patient is inappropriate
- Participation in another clinical trial with investigational medicinal product within past 30 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Not Yet Recruiting
2
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 46
Not Yet Recruiting
3
Örebro University Hospital
Örebro, Sweden, SE-701 85
Not Yet Recruiting
4
Karolinska University Hospital
Stockholm, Sweden, 171 76
Actively Recruiting
5
Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Not Yet Recruiting
Research Team
M
Magnus Nilsson, MD, Professor
CONTACT
L
Lisa Liu Burström, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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