BALLAD
BALLAD is the first randomised trial of chemotherapy after surgery for cancer of the small intestine, a rare tumour whose treatment has been borrowed from colon cancer; it tests both whether chemotherapy helps at all and whether adding oxaliplatin helps, and results are awaited.
Overview
BALLAD (Benefit of Adjuvant chemotherapy for small boweL ADenocarcinoma) is an international phase 3 trial, registered in France as PRODIGE 33 by the Dijon university hospital and run in parallel national registrations through the International Rare Cancers Initiative. Patients with resected stage I to III small bowel adenocarcinoma enter one of two groups: where the benefit of chemotherapy is uncertain they are randomised to observation or six months of LV5FU2, and where chemotherapy is intended they are randomised to LV5FU2 or FOLFOX. The primary endpoint is three-year disease-free survival, with overall survival at seven years.
The French registry record lists an estimated 100 patients with primary completion in September 2023 and no results; the protocol paper was published in 2019. The corpus's localised small bowel adenocarcinoma page cites BALLAD as the trial that will decide whether adjuvant chemotherapy, currently extrapolated from colon cancer, is justified in stage II disease.
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