The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases
34 affiliations
- 1Department of Surgery, University Surgical Cluster, National University Health System
- 2Saw Swee Hock School of Public Health, National University of Singapore
- 3Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore C/O NUHS Tower Block Level 8
- 4MD Andersen Cancer Center
- 5Verona University Hospital
- 6Imperial College Trials Unit-Cancer, Hammersmith Hospital, Imperial College Healthcare NHS Trust
- 7Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital
- 8The Chinese University of Hong Kong
- 9University Hospital Viamed Santa Elena
- 10Peter MacCallum Cancer Center
- 11Trinity St. James’s Cancer Institute
- 12University of Lille Centre Hospital
- 13Hospital Clínico Universitario of Valencia
- 14Amsterdam UMC location University of Amsterdam
- 15Heidelberg University Hospital
- 16Nihon University Hospital
- 17Catharina Hospital Eindhoven
- 18Yonsei University Hospital
- 19University Medical Center at Ho Chi Minh City
- 20The University of Hong Kong, Queen Mary Hospital
- 21Seoul National University Hospital
- 22Oxford University Hospital
- 23European Georges Pompidou Hospital
- 24National Cancer Centre, Singapore General Hospital
- 25Medical High School Hannover (MHH)
- 26Charité university school of Berlin
- 27Antoni van Leeuwenhoek Hospital, Netherlands Cancer Institute in Amsterdam
- 28Montpellier Cancer Hospital
- 29National Cancer Institute Mexico City
- 30Erasmus University Medical Center
- 31City of Hope Hospital
- 32Lyon University Centre Hospital
- 33Department of Clinical Science, Intervention and Technology, Department of Upper Abdominal Diseases, Karolinska Institutet, Karolinska University Hospital
- 34Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block, Level 7
Abstract
Background 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. Methods 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). Discussion 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. Trial registration NCT07241715.
Related
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BibTeX
@article{chia2026convergence,
title = {{The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases}},
author = {Daryl KA Chia and Yu Chuan Tan and Bee Choo Tai and Xin Yi Chan and Brian Badgwell and Maria Bencivenga and Piers Boshier and Andreas Brandl and Shannon Chan and Delia Cortes Guiral and Cuong Duong and Jessie A. Elliott and Clarisse Eveno and Tania Fleitas Kanonnikoff and Suzanne S. Gisbertz and Georg Martin Haag and Ken Hagiwara and Mark I. van Berge Henegouwen and Ignace De Hingh and Hyoung-Il Kim and Vo Duy Long and Simon Law and Hyuk-Joon Lee and Misha Luyer and Sheraz Markar and Antoine Mariani and Giovanni de Manzoni and Chin-Ann Johnny Ong and Beate Rau and Franziska Koehler and Safak Guel-Klein and Sun Young Rha and Johanna Van Sandick and Olivia Sgabura and Asim Shabbir and Alberto Mitsuo Leon Takahashi and Marieke Vollebergh and Bas Wijnhoven and Yanghee Woo and Ian Yu-Hong Wong and Hiroharu Yamashita and Olivier Glehen and Magnus Nilsson and Wei Peng Yong and Jimmy BY So},
journal = {BMC Cancer},
year = {2026},
month = jul,
doi = {10.1186/s12885-026-16423-2},
url = {https://doi.org/10.1186/s12885-026-16423-2},
note = {CC BY},
}
RIS
TY - JOUR
TI - The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases
AU - Daryl KA Chia
AU - Yu Chuan Tan
AU - Bee Choo Tai
AU - Xin Yi Chan
AU - Brian Badgwell
AU - Maria Bencivenga
AU - Piers Boshier
AU - Andreas Brandl
AU - Shannon Chan
AU - Delia Cortes Guiral
AU - Cuong Duong
AU - Jessie A. Elliott
AU - Clarisse Eveno
AU - Tania Fleitas Kanonnikoff
AU - Suzanne S. Gisbertz
AU - Georg Martin Haag
AU - Ken Hagiwara
AU - Mark I. van Berge Henegouwen
AU - Ignace De Hingh
AU - Hyoung-Il Kim
AU - Vo Duy Long
AU - Simon Law
AU - Hyuk-Joon Lee
AU - Misha Luyer
AU - Sheraz Markar
AU - Antoine Mariani
AU - Giovanni de Manzoni
AU - Chin-Ann Johnny Ong
AU - Beate Rau
AU - Franziska Koehler
AU - Safak Guel-Klein
AU - Sun Young Rha
AU - Johanna Van Sandick
AU - Olivia Sgabura
AU - Asim Shabbir
AU - Alberto Mitsuo Leon Takahashi
AU - Marieke Vollebergh
AU - Bas Wijnhoven
AU - Yanghee Woo
AU - Ian Yu-Hong Wong
AU - Hiroharu Yamashita
AU - Olivier Glehen
AU - Magnus Nilsson
AU - Wei Peng Yong
AU - Jimmy BY So
PY - 2026
DA - 2026/07/01
JO - BMC Cancer
DO - 10.1186/s12885-026-16423-2
UR - https://doi.org/10.1186/s12885-026-16423-2
AB - Background 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. Methods 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). Discussion 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. Trial registration NCT07241715.
SN - 1471-2407
ER -