Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
Status:
NOT_YET_RECRUITING
Trial end date:
2034-01-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate the impact of conversion surgery on overall survival (OS) in patients with gastric cancer peritoneal metastases (GCPM) who show a good response to preoperative systemic therapy (including first-line chemotherapy with or without targeted therapy and/or immunotherapy) with or without peritoneal-directed chemotherapy.\]. The main question it aims to answer is:
(i) Will Conversion surgery be associated with improved overall survival (OS) in patients with GCPM who respond well to preoperative systemic therapy, compared to patients who do not undergo surgery? (ii) Will Quality of life be comparable or improved in patients who undergo conversion surgery compared to patients receiving palliative chemotherapy as measured by the QLQ-C30 questionnaire?
If there is a comparison group: Researchers will compare Arm 1 (Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to Arm 2 (systemic therapy alone (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to see if the conversion surgery will be associated with improved overall survival (OS) in Arm 1.
Participants will be randomized to either Arm 1 or Arm 2.
* For Arm 1, participants will go for conversion surgery then continue systemic therapy.
* For Arm 2, participants will continue systemic therapy.
Radiological assessment will be performed every 6 months or upon progression of disease, whichever comes earlier.
Phase:
PHASE2
Details
Lead Sponsor:
National University Hospital, Singapore
Collaborators:
Chinese University of Hong Kong Erasmus Medical Center Karolinska University Hospital M.D. Anderson Cancer Center Peter MacCallum Cancer Centre, Australia Queen Mary Hospital, Hong Kong Seoul National University Hospital Universita di Verona University Hospital, Lille University Hospital, Montpellier University of Lyon University of Oxford