Clinical trial · Interventional
Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Stage IV | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Metastasis | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conversion Surgery | Procedure | — | UNRESOLVED |
| Systemic Therapy/Standard of Care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot
- interventionNames
- Procedure: Conversion Surgery
- type
- ACTIVE_COMPARATOR
- label
- systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d
- interventionNames
- Drug: Systemic Therapy/Standard of Care
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From enrollment to the end of follow-up at 36 months.
- description
- Time from randomization to death from any cause. Patients alive or lost to follow-up at analysis will be censored at the date last known alive.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * GCPM detected on surgical exploration and demonstrated by histology or cytology * Primary GC not resected * Age \> 21 (or \> 18 as allowed by individual institution review boards) Exclusion Criteria: * Pregnant and lactating females * Prior surgical treatment for GC involving resection * Clinical or radiological progression during 1st line systemic treatment
References
Publications (0)
Data not yet available