Phase II randomized trial evaluating modified FOLFIRINOX and FOLFOX in the treatment of locally advanced or metastatic small bowel adenocarcinoma [FIRE-12]

Condition studied

locally advanced or metastatic small bowel adenocarcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

Progression-free survival, defined as the time from the date of randomization to the date of first radiological disease progression according to RECIST 1.1 or the date of death from any cause. Date of the last contact known alive respectively date of the last tumor assessment known progression-free.

Endpoint detail

Overall survival (OS), is defined as the time from the date of randomisation to the date of death (from any cause). The date of the last contact known alive respectively date of the last tumor assessment known progression-free will be censored at the date of last data entry., Objective respone rate (ORR), defined as rate of complete (CR) and partial responses (PR) during study treatment compared to baseline according to RECIST 1.1., Depth of response (DpR), defined as change in percent from baseline to smallest tumor diameter (measurements according to RECIST 1.1 definition)., Type, incidence, severity, and causal relationship to study treatment of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 6.0)., Quality of life (QoL) as assessed with the QoL questionnaire EQ-5D-5L