Advanced Biliary Cancer Clinical Trial
Official title:
A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination With Cetuximab in Patients With Advanced Biliary Cancer.
A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.
The BINGO trial is an open-label randomized phase II study evaluating the efficacy and
tolerance of gemcitabine-oxaliplatin combination chemotherapy (GEMOX regimen) alone or in
combination with cetuximab in patients (pts) with ABC. The BINGO study also comprises
ancillary translational research and functional imaging studies which aim to identify
markers predictive for treatment efficacy in ABC.
All eligible pts will be randomized 1:1 to receive:
- Arm A: GEMOX alone every two weeks.
- Arm B: GEMOX + cetuximab every two weeks.
Randomization will be stratified according to:
1. tumor stage (locally advanced vs metastatic),
2. primary tumor location (gallbladder vs non-gallbladder),
3. prior treatments (surgery or radiotherapy or brachytherapy or photodynamic therapy
[PDT] or adjuvant chemotherapy vs none),
4. center. EGFR tumor status has to be assessed for every pt by immunohistochemistry (IHC)
using biopsy or surgical material, at any time prior to inclusion into the study, but
it is neither an inclusion/exclusion criterion nor a stratification factor.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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