Small Bowel Adenocarcinoma Clinical Trial
Official title:
PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma
The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA)
remains unproven and awaits the results of a large, global, prospective, phase III,
randomised, controlled trial. Across the 830 million population of North America and Europe,
there are approximately 3,000 patients with stage I-III SBA every year who would be
potentially eligible for such an adjuvant chemotherapy trial.
Given the absence of good-quality and evidence-based data, it has been agreed that a trial
considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with
stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant
chemotherapy is uncertain. For those patients with stage I-III SBA who, with their
oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence
are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation
between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin
chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those
patients who do not consent to be randomised will be offered registration to allow
collection of demographic, clinicopathological and survival data, thereby making optimal use
of the rare patient population available. In addition, archival Formalin Fixed Paraffin
Embedded (FFPE) tissue and contemporaneous venous blood samples will be collected from every
registered patient to allow molecular profiling and future translational research. A
questionnaire about underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch
syndrome etc) will be completed along with the other collected data on all registered
patients.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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