{"entity":{"id":"ballad","kind":"trial","name":"BALLAD","aka":["PRODIGE 33 - BALLAD","PRODIGE 33","GLOBAL BALLAD"],"tldr":"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.","summary":"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.\n\nThe 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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02502370","url":"https://clinicaltrials.gov/study/NCT02502370"}],"tags":["soc-trials"],"related":[],"cancers":["localised-small-bowel-adenocarcinoma","small-bowel"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","folfox","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02502370","phase":"3","setting":"Resected stage I to III small bowel adenocarcinoma: an international randomised trial of adjuvant chemotherapy, with observation against fluorouracil and leucovorin (LV5FU2) where the benefit of chemotherapy is uncertain, and LV5FU2 against FOLFOX where chemotherapy is intended, with three-year disease-free survival as the primary endpoint","sponsor":"Centre Hospitalier Universitaire Dijon (PRODIGE)","enrolled":100,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/ballad/","neighbours":{"cancer":[{"id":"localised-small-bowel-adenocarcinoma","kind":"cancer","name":"Localised small bowel adenocarcinoma (stage I to III, resected)","route":"/cancers/localised-small-bowel-adenocarcinoma/"},{"id":"small-bowel","kind":"cancer","name":"Small intestine cancer (small bowel adenocarcinoma)","route":"/cancers/small-bowel/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}]}}