Is pre-trial quality assurance necessary? Experiences of the CONVERT Phase III randomized trial for good performance status patients with limited-stage small-cell lung cancer.

ABSTRACT:

Objective

This study is an analysis of the pre-trial quality assurance (QA) exercises submitted by clinicians from radiotherapy (RT) centres across Europe and Canada to qualify for participation in the CONVERT trial.

Methods

QA exercises submitted by 64 clinicians at 64 RT centres were included in this analysis. The exercises included the completion of a trial-specific questionnaire and submission of a treatment plan, for both trial arms, for a patient fitting the eligibility criteria of the trial. This article describes the QA programme set up for the CONVERT trial and identifies deviations from the trial protocol. Patient eligibility, disease and critical structure outlining and treatment planning technique were assessed.

Results

Results from QA trial-specific quest

SUBMITTER: Groom N 

PROVIDER: S-EPMC4075528 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature