Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorImperial College London
About this trial
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 development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis.
Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile.
Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease).
Eligibility criteria
Qualifiers
Gastric adenocarcinoma (Tx, Nx) 1,2,3
Peritoneal cytology +ve or PCI ≤ 3
No solid organ metastasis 2
HER2 -ve
Disqualifiers
PCI ≥ 4
Solid organ metastasis
Positive lymph node disease beyond field of D2 lymphadenectomy
Peritoneal adhesions precluding complete laparoscopy
Trial design
Treatments tested in this trial
- Doxorubicin and Cisplatin
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov