Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)

NCT07241715 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024/00052
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Gastric Cancer Stage IV; Peritoneal Metastasis

Keywords

Gastric cancer; Peritoneal Metastasis

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  From enrollment to the end of follow-up at 36 months.

Secondary Outcomes (5)

• Progression-free survival (PFS)

  From enrollment to the end of follow-up at 36 months.

• Surgical outcomes

  From surgery to 90 days post-operation, and up to the end of follow-up at 36 months for late events.

• Quality of Life - Global Health Status (EORTC QLQ-C30

  Baseline and scheduled follow-up visits up to 36 months.

• Quality of Life - Gastro-Oesophageal Symptoms (EORTC QLQ-OG25)

  Baseline and scheduled follow-up visits up to 36 months.

• Quality of Life - General Health Status (EQ-5D-5L)

  Baseline and scheduled follow-up visits up to 36 months.

Study Arms (2)

Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot

EXPERIMENTAL

Procedure: Conversion Surgery

systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d

ACTIVE COMPARATOR

Drug: Systemic Therapy/Standard of Care

Interventions

Conversion Surgery PROCEDURE

Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy

Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot

Systemic Therapy/Standard of Care DRUG

systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy

systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant and lactating females
• Prior surgical treatment for GC involving resection
• Clinical or radiological progression during 1st line systemic treatment

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Karolinska University Hospital: collaborator
• University of Lyon: collaborator
• M.D. Anderson Cancer Center: collaborator
• Seoul National University Hospital: collaborator
• University of Oxford: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• Queen Mary Hospital, Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator
• University Hospital, Lille: collaborator
• Erasmus Medical Center: collaborator
• University Hospital, Montpellier: collaborator
• Universita di Verona: collaborator

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Conversion to Open Surgery; Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Professor Jimmy So

CONTACT

+65 6908 2222; xchan@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2034
• Last Updated: November 21, 2025

Record last verified: 2025-10