Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
NCT ID: NCT07241715
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
300 participants
INTERVENTIONAL
2026-01-31
2034-01-31
Brief Summary
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(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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot
Conversion Surgery
Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d
Systemic Therapy/Standard of Care
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
Interventions
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Conversion Surgery
Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
Systemic Therapy/Standard of Care
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Primary GC not resected
* Age \> 21 (or \> 18 as allowed by individual institution review boards)
Exclusion Criteria
* Prior surgical treatment for GC involving resection
* Clinical or radiological progression during 1st line systemic treatment
21 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
University of Lyon
OTHER
M.D. Anderson Cancer Center
OTHER
Seoul National University Hospital
OTHER
University of Oxford
OTHER
Peter MacCallum Cancer Centre, Australia
OTHER
Queen Mary Hospital, Hong Kong
OTHER
Chinese University of Hong Kong
OTHER
University Hospital, Lille
OTHER
Erasmus Medical Center
OTHER
University Hospital, Montpellier
OTHER
Universita di Verona
OTHER
National University Hospital, Singapore
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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2024/00052
Identifier Type: -
Identifier Source: org_study_id
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