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Trial registered on ANZCTR


Registration number
ACTRN12614001219673
Ethics application status
Approved
Date submitted
22/10/2014
Date registered
19/11/2014
Date last updated
10/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multiparametric Magnetic Resonance Imaging (MRI) as an Outcome Predictor for Anal Canal Cancer Managed with Chemoradiotherapy
Scientific title
Multiparametric MRI as a Predictor of Tumour Response in Patients with Anal Canal Cancer Managed with Chemoradiotherapy
Secondary ID [1] 285527 0
CMNDRO-1201
Universal Trial Number (UTN)
Trial acronym
MPM MRI Anal SCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Cancer 293345 0
Condition category
Condition code
Cancer 293611 293611 0 0
Bowel - Anal

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Single arm, multicentre, prospective, observational biomarker study.

Patients will have standard chemotherapy and radiotherapy. Patients participating in this study will have a multiparametric MRI at the following four time points:
1. Prior to chemoradiotherapy
2. During the second week of treatment
3. During the fourth week of treatment
4. At 6-8 weeks post treatment

A Multiparametric MRI incorporates standard morphological as well as diffusion weighted and dynamic contrast enhanced sequences. Each MRI takes approximately 45 minutes. All sequences will be performed on all patients at each of the 4 time points.

Observation post treatment is for 6 months.

Intervention code [1] 290470 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293420 0
Correlation of change in Standard Morphological MRI with tumour response as determined by DRE +/- imaging
Timepoint [1] 293420 0
6 months
Primary outcome [2] 293593 0
Correlation of change in Diffusion Weighted MRI with tumour response as determined by DRE +/- imaging
Timepoint [2] 293593 0
6 months
Primary outcome [3] 293595 0
Correlation of change in Dynamic Contrast Enhanced MRI with tumour response as determined by DRE +/- imaging
Timepoint [3] 293595 0
6 months
Secondary outcome [1] 310993 0
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
Timepoint [1] 310993 0
Study completion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3061 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 3062 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 3064 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 8831 0
2050 - Camperdown
Recruitment postcode(s) [2] 8833 0
2170 - Liverpool
Recruitment postcode(s) [3] 8832 0
2304 - Mayfield

Funding & Sponsors
Funding source category [1] 290129 0
Other Collaborative groups
Name [1] 290129 0
Hunter Translational Cancer Research Unit (HTCRU) Priority Research Centre for Cancer (PRC Cancer)

Address [1] 290129 0
C/O Calvary Mater Newcastle Hospital,
Edith St, Waratah NSW 2298
Country [1] 290129 0
Australia
Funding source category [2] 290130 0
Other Collaborative groups
Name [2] 290130 0
Royal Australian and New Zealand College of Radiologists
Address [2] 290130 0
Level 9, 51 Druitt Street, SYDNEY NSW 2000
Country [2] 290130 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Jones
Address
Calvary Mater Newcastle Hospital
Edith Street Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 288841 0
None
Name [1] 288841 0
Address [1] 288841 0
Country [1] 288841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291837 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 291837 0
Locked Bag No 1, New Lambton NSW 2305
Ethics committee country [1] 291837 0
Australia
Date submitted for ethics approval [1] 291837 0
Approval date [1] 291837 0
13/12/2012
Ethics approval number [1] 291837 0
HREC/12/HNE/408

Summary
Brief summary
This observational study aims to explore the use of diffusion-weighted magnetic resonance imaging (DW-MRI) and dynamic contrast enhanced MRI (dCE-MRI) in predicting treatment outcome in patients with anal cancer.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with anal canal squamous cell carcinoma (SCC) managed with definitive chemoradiotherapy with concurrent Mitomycin-C and 5-FU.

Study details
All participants will continue their standard chemotherapy and radiotherapy as planned. Patients participating in this study will have multiparametric MRI's performed at the following four time points: 1) prior to chemoradiotherapy, 2) during the second week of treatment, 3) during the fourth week of treatment, 4) at 6-8 weeks post treatment. Each scan involves the use of an injected contrast agent and is of approximately 45 minutes length. Participants will be followed-up for 6 months to determine treatment outcomes. Correlations between the different types of MRIs and tumour response will determine whether DW-MRI and dCE-MRI can predict tumour response and treatment outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52222 0
Dr Michael Jones
Address 52222 0
Department of Radiation Oncology
Calvary Mater Newcastle
Edith Street Waratah NSW 2298
Country 52222 0
Australia
Phone 52222 0
+61 2 4014 3632
Fax 52222 0
+61 2 4014 3128
Email 52222 0
Michael.jones@calvarymater.org.au
Contact person for public queries
Name 52223 0
Dr Michael Jones
Address 52223 0
Department of Radiation Oncology
Calvary Mater Newcastle Hospital
Edith Street Waratah NSW 2298
Country 52223 0
Australia
Phone 52223 0
+61 2 4014 3632
Fax 52223 0
+61 2 4014 3128
Email 52223 0
Michael.jones@calvarymater.org.au
Contact person for scientific queries
Name 52224 0
Dr Michael Jones
Address 52224 0
Department of Radiation Oncology
Calvary Mater Newcastle Hospital
Edith Street Waratah NSW 2298
Country 52224 0
Australia
Phone 52224 0
+61 2 4014 3632
Fax 52224 0
+61 2 4014 3128
Email 52224 0
Michael.jones@calvarymater.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary