Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)

National University Health System (NUHS)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Gastric Cancer Stage IV; Peritoneal Metastasis

Treatments: Drug: Systemic Therapy/Standard of Care; Procedure: Conversion Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07241715

2024/00052

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

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

Experimental group

Treatment:

Procedure: Conversion Surgery

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

Active Comparator group

Treatment:

Drug: Systemic Therapy/Standard of Care