Status:
NOT_YET_RECRUITING
Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer
Lead Sponsor:
Imperial College London
Conditions:
Gastric Cancer
Peritoneal Metastases
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent...
Detailed Description
BACKGROUND: There remains therefore an important, and as yet unmet, clinic need to improve survival of patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minima...
Eligibility Criteria
Inclusion
- Gastric adenocarcinoma (Tx, Nx) 1,2,3
- Peritoneal cytology +ve or PCI ≤ 3
- No solid organ metastasis 2
- HER2 -ve
- Male/female
- Treatment naïve
- BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2
- WHO performance status ≤ 1
- Dysphagia score ≤ 2
- Informed written consent
Exclusion
- PCI ≥ 4
- Solid organ metastasis
- Positive lymph node disease beyond field of D2 lymphadenectomy
- Peritoneal adhesions precluding complete laparoscopy
- Ascites (greater than trace amount)
- Malignant pleural effusion
- Mechanical bowel obstruction (with the exception of gastric outlet obstruction)
- HER2 +ve
- Patients eligible for immunotherapy
- Uncontrolled co-morbidity
- single/multiple organ failure
- BMI \< 18.5 kg/m2 or \> 40 kg/m2
- WHO performance status \> 1
- Dysphagia score \> 2
- Contraindication to chemotherapy
- Pregnancy or breastfeeding
- Haemoglobin \<90 g/dL uncorrected with blood transfusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05318794
Start Date
November 1 2023
End Date
July 1 2030
Last Update
September 13 2023
Active Locations (1)
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1
Imperial College London, Hammersmith Hospital Campus
London, United Kingdom, W12 0HS