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BMC Cancer
Published in: BMC Cancer 1/2015

Open Access 01-12-2015 | Study protocol

Multiparametric MRI as an outcome predictor for anal canal cancer managed with chemoradiotherapy

Authors: Michael Jones, George Hruby, Peter Stanwell, Sarah Gallagher, Karen Wong, Jameen Arm, Jarad Martin

Published in: BMC Cancer | Issue 1/2015

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Abstract

Background

Organ-preserving chemo-radiotherapy (CRT) is the standard of care for non-metastatic anal squamous cell carcinoma (SCC). The optimal dosing schedules are yet to be determined. To improve local control rates, dose escalation has been investigated but found to not increase efficacy at the expense of increased toxicity for an unselected patient population.
Diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) performed during CRT have early data suggesting it to be an effective tool in predicting later tumour response for SCC in related body sites.
By performing multi-parametric MRI (mpmMRI) incorporating standard morphological, DWI and DCE sequences, we aim to determine whether the early changes in multi-parametric parameters during CRT can predict for later response in anal SCC. This may create opportunities to investigate treatment adaptation, either intensification or de-escalation, during CRT.

Methods/Design

This protocol describes a prospective non-interventional multi-centre single-arm clinical trial. Twenty eligible patients with histologically confirmed non-metastatic anal SCC will receive standard definitive CRT and undergo multi-parametric MRI’s at the following 4 time points; prior to treatment, during the second and fourth weeks of treatment and 6-8 weeks following treatment.
Complete response will be defined by the absence of tumour persistence or recurrence as determined by clinical examination at 6 months.
Images will be retrospectively analysed to determine the apparent diffusion coefficient and tumour perfusion coefficients (Ktrans and Kep) at each time point. The Mann-Whitney-Wilcoxon Test will be utilised to compare the change in these parameters for responder’s verses non-responders.

Discussion

If validated, mpmMRI, along with other risk factors, can be used to stratify patients and guide radiation dosing in a prospective trial. Informed individualisation of treatment intensity should help us achieve our goals of improved efficacy and reduced toxicity.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001219​673 (19/11/2014).
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Metadata
Title
Multiparametric MRI as an outcome predictor for anal canal cancer managed with chemoradiotherapy
Authors
Michael Jones
George Hruby
Peter Stanwell
Sarah Gallagher
Karen Wong
Jameen Arm
Jarad Martin
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-015-1244-7

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