A phase III randomized clinical trial evaluating perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB)
Abstract
4007
Background:
Locally advanced Gallbladder cancers (LAGBC)initially deemed not suitable for R0 resection receive either neoadjuvant chemotherapy (NACT)or neoadjuvant chemoradiation (NACRT)downstaging for resection and to improve outcomes.
Methods:
This is a randomized phase 3 trial (NCT02867865) that included fit patients with LAGBC adenocarcinoma,. T3/T4 with liver infiltration ( > 2cm, < 5cm); N1 nodal status; obstructive jaundice (type I/II biliary obstruction) ;duodenal or colonic abutment with no mucosal infiltration , < 180°vascular involvement. The patients were randomized (1:1) to NACT arm (Gemcitabine + platinum for four cycles) versus NACRT arm (55 -57Gy with concurrent gemcitabine followed by two cycles of chemotherapy) and were then evaluated for surgery. A sample size of 314 patients was required to detect a 5.5 months difference (11 mo.to 16.5 mo in the test arm) with median overall survival (OS) as the primary endpoint (hazard ratio, 0.7; 2-sided α = 0.05; β = 0.2). Secondary endpoints were event free survival (EFS),R0 resection rates and post-operative complication rates. Due to slow accrual Institutional Ethics committee requested the investigators for interim analysis and approval was obtained for the same.
Results:
From Oct 2016 to Sept 2024
,
124 patients (64 NACT, 60 NACTRT)were enrolled at 2 centers. At the time of analysis 93 OS events were observed in 124 patients. Median follow-up was 62 (range 6.9-94) months. More number of patients underwent R0…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 314 participants or records.
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