An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma.

ABSTRACT:

Objectives

The objective of this study was to explore the association between health-related quality of life (HRQoL) and the recommended phase 2 dose in a phase I clinical trial according to the Time to HRQoL deterioration approach (TTD).

Setting

This is a phase I dose-escalation trial of transarterial chemoembolisation (TACE) with idarubicin-loaded beads performed in cirrhotic patients with hepatocellular carcinoma. Patients had to complete the EORTC QLQ-C30 HRQoL questionnaire at baseline and at days 15, 30 and 60 after TACE.

Participants

Patients aged ≥18 years with HCC unsuitable for curative treatments were evaluated for the study (N=21).

Primary and secondary outcome measurements

The primary objective was to determine the maximum tolerated dose (MTD) of i

SUBMITTER: Anota A 

PROVIDER: S-EPMC4932346 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature