Multiparametric Magnetic Resonance Imaging (MRI) as an Outcome Predictor for Anal Canal Cancer Managed with Chemoradiotherapy

Not Applicable

Completed

• Conditions: Anal Cancer; Cancer - Bowel - Anal

• Registration Number: ACTRN12614001219673
• Lead Sponsor: Dr Michael Jones

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Patient capable of providing informed consent
2.Patient deemed suitable for protocol treatment as
assessed by Radiation and Medical Oncologists
3.Histological diagnosis of invasive primary squamous
cell carcinoma of the anal canal
4.TNM Stage: T2-4, N0-3 based on the
following diagnostic workup
a.History & physical examination
b.Digital Rectal Exam (DRE) stating primary size and
distance from anal verge
c.Groin examination with documentation of any
lymphadenopathy (location: right vs. left; medial vs.
lateral; mobile vs. fixed; and size)
d.Clinically positive nodes
i .Small inguinal nodes < 1cm in size felt to be clinically
positive must be confirmed via biopsy
ii. A biopsy is not needed for enlarged inguinal,
perirectal or pelvic nodes on examination or imaging
if >1cm and considered to be clinically positive
e.Anal biopsy
f.CT abdomen and pelvis
g.PET/CT

Exclusion Criteria

1.ECOG performance status >2
2.Significant comorbidities that would interfere with
the completion of treatment
3.Renal insufficiency (Creatinine > 150)
4.Prior radiotherapy to the pelvis that would overlap in
the treatment fields
5.Prior surgery for cancer of the anus that removed all
macroscopic cancer
6.Prior systemic chemotherapy for anal cancer
7.Evidence of distant metastases (M1) if this precludes
radical pelvic treatment
8.Women who are pregnant or lactating
9.Inability to have a MRI due to:
a.Implanted magnetic metal e.g. intraocular metal
b.Pacemaker / Implantable defibrillator
c.Extreme claustrophobia

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of change in Standard Morphological MRI with tumour response as determined by DRE +/- imaging [6 months];Correlation of change in Diffusion Weighted MRI with tumour response as determined by DRE +/- imaging[6 months];Correlation of change in Dynamic Contrast Enhanced MRI with tumour response as determined by DRE +/- imaging<br>[6 months]

Secondary Outcome Measures

Name	Time	Method
Determine the feasibility of performing Multiparametric MRI during chemoradiotherapy for anal cancer by reflecting on our experience of the logistical, economic and clinical aspects of the trial [Study completion<br>]