Trials / Not Yet Recruiting
Not Yet RecruitingNCT07241715
Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
- Status
- Not Yet Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- National University Hospital, Singapore · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Conversion Surgery | Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy |
| DRUG | Systemic Therapy/Standard of Care | systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy |
Timeline
- Start date
- 2026-01-01
- Primary completion
- 2034-01-01
- Completion
- 2034-01-01
- First posted
- 2025-11-21
- Last updated
- 2025-11-21
Source: ClinicalTrials.gov record NCT07241715. Inclusion in this directory is not an endorsement.