A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol.

ABSTRACT:

Introduction

Neoadjuvant chemotherapy (NACT) is considered the current standard for locally advanced gallbladder cancer (GBC). There is no consensus on the optimal neoadjuvant approach. A pilot study from our institution has shown improved overall survival (OS) and progression-free survival (PFS) with neoadjuvant chemoradiation (NACRT). The present randomised phase III trial is designed to compare NACRT with NACT alone and will test the superiority of chemoradiation in terms of tumour downstaging and improvement in OS.

Methods and analysis

Patients with biopsy-proven locally advanced GBC (T3-4) with predefined clinical-radiological features will be randomised to the gemcitabine-based chemotherapy-alone arm or the chemoradiation arm. Patients with resectable disease or with d

SUBMITTER: Engineer R 

PROVIDER: S-EPMC6609079 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature