The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases
The benefit of surgical resection in addition to systemic therapy in patients with gastric/gastroesophageal cancer and peritoneal metastases (GCPM) is controversial. This CONVERGENCE trial aims to study the potential benefits of conversion surgery in patients with peritoneal metastases. This is a prospective, pragmatically designed, multicentre, randomized, investigator-initiated phase II/III trial. Patients with synchronous GCPM who have undergone either systemic therapy (including 1 L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy with favourable response would be randomized in 1:1 ratio to Arm 1 (Conversion surgery followed by systemic +/- peritoneal directed chemotherapy or Arm 2 (continual systemic +/- peritoneal directed chemotherapy). In the initial Phase II trial, 136 patients will be recruited and randomized. The primary endpoint is overall survival; main secondary endpoints include progression-free survival, R0 resection and complete cytoreduction rates, surgical morbidity/mortality and quality of life outcomes. If pre-defined thresholds of improved overall survival are met, the trial will expand to adequately power a phase III randomized controlled trial ( n = 300). If survival benefit in conversion gastrectomy is demonstrated, this could potentially be a new standard of care for patients with peritoneal metastases from gastric or gastroesophageal junction cancer. Conversely, negative findings may lead to the avoidance of unnecessary surgical procedures and morbidity in these patients. NCT07241715.
Authors
- Ian Yu-hong Wong
- Wei Peng Yong (ORCID: https://orcid.org/0000-0003-4404-3777)
- Mark I. van Berge Henegouwen (ORCID: https://orcid.org/0000-0001-8689-3134)
- Xin Yi Chan (ORCID: https://orcid.org/0000-0003-3579-4907)
- Georg Martin Haag (ORCID: https://orcid.org/0000-0002-9410-9968)
- Delia Cortés‐Guiral (ORCID: https://orcid.org/0000-0002-3834-2271)
- Hiroharu Yamashita (ORCID: https://orcid.org/0000-0002-9468-3716)
- Johanna van Sandick
- Daryl Ka Chia
- Bee Choo Tai (ORCID: https://orcid.org/0000-0002-4420-7746)
- Magnus Nilsson (ORCID: https://orcid.org/0000-0002-6215-8132)
- Chin‐Ann Johnny Ong (ORCID: https://orcid.org/0000-0003-4573-7738)
- Andreas Brandl (ORCID: https://orcid.org/0000-0003-1990-2584)
- Beate Rau (ORCID: https://orcid.org/0000-0001-5820-6907)
- Antoine Mariani (ORCID: https://orcid.org/0000-0002-9626-0004)
- Hyoung‐Il Kim (ORCID: https://orcid.org/0000-0002-6134-4523)
- A. Takahashi
- Franziska Koehler
- Misha Luyer
- Yu Chuan Tan
- Olivia Sgabura
- Tania Fleitas Kanonnikoff
- Piers Boshier
- Maria Bencivenga
- Marieke Vollebergh
- Shannon Chan
- Cuong Duong
- Sheraz Markar
- Brian Badgwell
- Hyuk-Joon Lee
- Suzanne S. Gisbertz
- Jimmy BY So
- Ken Hagiwara
- Giovanni de Manzoni
- Olivier Glehen
- Simon Law
- Asim Shabbir
- Ignace De Hingh
- Vo Duy Long
- Bas Wijnhoven
- Sun Young Rha
- Safak Guel-Klein
- Yanghee Woo
- Jessie A. Elliott
- Clarisse Eveno
Institutions
- Nihon University (JP)
- University of Verona (IT)
- Karolinska University Hospital (SE)
- The University of Texas MD Anderson Cancer Center (US)
- Radboud University Nijmegen (NL)
- Imperial College Healthcare NHS Trust (GB)
- National University of Singapore (SG)
- Chinese University of Hong Kong (HK)
- Lyon College (US)
- Yonsei University (KR)
- Heidelberg University (DE)
- Université de Lille (FR)
- Peter MacCallum Cancer Centre (AU)
- Queen Mary Hospital (CN)
- Catharina Ziekenhuis (NL)
- Erasmus MC (NL)
- University Hospital Heidelberg (DE)
- Seoul National University Hospital (KR)
- Centre Hospitalier Universitaire de Lille (FR)
- Medizinische Hochschule Hannover (DE)
- University of Oxford (GB)
- Lille’s Cardiology Hospital (FR)
- Centre Hospitalier Universitaire de Montpellier (FR)
- Hospital Clínico Universitario de Valencia (ES)
- Communauté urbaine de Lyon (FR)
- University Medical Center HCMC (VN)
- Hôpital Européen Georges-Pompidou (FR)
- National University Cancer Institute, Singapore (SG)
- City of Hope (US)
- Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NL)
- Surugadai Nihon University Hospital (JP)
- National Cancer Centre Singapore (SG)
- Vietnam National Children's Hospital (VN)
- Institut de Recherche en Cancérologie de Montpellier (FR)
- National University Health System (SG)
- Amsterdam University Medical Centers (NL)
- Instituto Nacional de Cancerología (MX)
- St. James's Hospital (IE)
- Hospital Universitario Infanta Leonor (ES)
- Cancer Center Amsterdam (NL)
- Charité - Universitätsmedizin Berlin (DE)
- University of Amsterdam (NL)
- University of Hong Kong (HK)
Publication Details
- Journal
- BMC Cancer
- Published
- 2026-07-27
- DOI
- https://doi.org/10.1186/s12885-026-16423-2
- Primary Topic
- Gastric Cancer Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 0.00