Phase 2 study of capecitabine and oxaliplatin for advanced adenocarcinoma of the small bowel and ampulla of Vater
The first prospective trial in small bowel adenocarcinoma found that the colorectal cancer regimen CAPOX shrank tumours in half of patients, and it became the backbone of treatment and of the adjuvant BALLAD trial.
Overview
Single-centre phase 2 study of 30 patients with untreated advanced adenocarcinoma of the small bowel or ampulla of Vater treated with capecitabine and oxaliplatin (CAPOX) every three weeks.
The objective response rate was 50 percent, median time to progression 11.3 months and median overall survival 20.4 months, with results in the small bowel subgroup at least as good. The regimen was adopted as a standard for advanced disease and the basis for adjuvant trials.
- Objective response rate 50 percent; median time to progression 11.3 months; median overall survival 20.4 months.
Fluoropyrimidine plus oxaliplatin is the first-line chemotherapy for advanced small bowel adenocarcinoma and the regimen tested after surgery in BALLAD.
- Small single-arm study mixing small bowel and ampullary cancers.
- No randomised comparison exists for first-line chemotherapy in this disease.
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