Small Bowel Adenocarcinoma Clinical Trial
Official title:
BALLAD BELGIUM: A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma
An open-label, randomised, controlled, multi-centre, trial with disease free survival as the primary end point. The worldwide collaboration is referred to as GLOBAL BALLAD and consists of a number of individual parallel prospective studies addressing the same objectives with similar designs brought together under the framework of the International Rare Cancer Initiative. This protocol is for BALLAD BELGIUM, which is the component of GLOBAL BALLAD.
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 R0 resected and potentially cured 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-IV SBA in whom the oncologist and patient feel that the benefit of adjuvant
chemotherapy is uncertain. For those patients with stage I-IV 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, epidemiological 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.
The trial hypotheses are that:
1. Adjuvant chemotherapy results in an improved outcome (DFS and OS) over observation alone
after potentially curative R0 surgery for stage I, II, III and IV SBA
2. Adjuvant fluoropyrimidine and oxaliplatin chemotherapy results in an improved outcome
(DFS and OS) over fluropyrimidine alone after potentially curative R0 surgery for stage
I, II, III and IV SBA.
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