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Trial registered on ANZCTR


Registration number
ACTRN12616001690448
Ethics application status
Approved
Date submitted
6/12/2016
Date registered
8/12/2016
Date last updated
8/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-parametric MRI for Therapeutic Response Prediction in Rectal Cancer
Scientific title
Multi-parametric Magnetic Resonance Imaging (MRI) for Therapeutic Response Prediction in Rectal Cancer
Secondary ID [1] 290697 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MRI Rectal Cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer 301246 0
Condition category
Condition code
Cancer 301005 301005 0 0
Bowel - Back passage (rectum) or large bowel (colon)

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

Patients will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to the patient's treatment by participating in this study. Patients participating in this study will have multi-parametric MRI and PET/CT at the following 3 time-points:
1. Prior to chemoradiotherapy
2. During the third week of chemoradiotherapy
3. Post chemoradiotherapy, within 1 week prior to surgery.

A multi-parametric MRI incorporates standard morphological as well as diffusion weighted imaging and dynamic contrast enhanced sequences.

The total follow-up duration will be 2 years from date of surgery.

Intervention code [1] 296581 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300423 0
Correlation of multi-parametric MRI (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE)) at 3 Tesla with surgical histopathology tumour regression grade (TRG).

Histopathological assessment will be performed on surgical specimens. TRG assessment will be performed as per the modified classification of Ryan et al set out in the AJCC Cancer Staging Manual, 7th Edition as follows:

TRG 0 (complete response) - no viable cancer cells
TRG 1 (moderate response) - single cells or small groups of cancer cells
TRG 2 (minimal response) - residual cancer outgrown by fibrosis
TRG 3 (poor response) - minimal or no tumour kill; extensive residual cancer.
Timepoint [1] 300423 0
At baseline pre-chemoradiotherapy, week 3 of chemoradiotherapy, and post-chemoradiotherapy (within 1 week prior to surgery)
Secondary outcome [1] 329933 0
Correlation of DCE MRI with histopathology tumour regression grade (TRG).

Histopathological assessment will be performed on surgical specimens. TRG assessment will be performed as per the modified classification of Ryan et al set out in the AJCC Cancer Staging Manual, 7th Edition.
Timepoint [1] 329933 0
At baseline pre-chemoradiotherapy, week 3 of chemoradiotherapy, and post-chemoradiotherapy (within 1 week prior to surgery)
Secondary outcome [2] 329934 0
Correlation of DWI MRI with histopathology tumour regression grade (TRG).

Histopathological assessment will be performed on surgical specimens. TRG assessment will be performed as per the modified classification of Ryan et al set out in the AJCC Cancer Staging Manual, 7th Edition.
Timepoint [2] 329934 0
At baseline pre-chemoradiotherapy, week 3 of chemoradiotherapy, and post-chemoradiotherapy (within 1 week prior to surgery)
Secondary outcome [3] 329935 0
Correlation of multi-parametric MRI and PET in combination with histopathology tumour regression grade (TRG).

Histopathological assessment will be performed on surgical specimens. TRG assessment will be performed as per the modified classification of Ryan et al set out in the AJCC Cancer Staging Manual, 7th Edition.

Timepoint [3] 329935 0
At baseline pre-chemoradiotherapy, week 3 of chemoradiotherapy, and post-chemoradiotherapy (within 1 week prior to surgery)
Secondary outcome [4] 329936 0
Correlation of MRI and PET biomarkers with 2 year disease free survival.

MRI and PET biomarkers are exploratory. Disease free survival will be assessed by 3 monthly clinical follow-up until total 2 years following date of surgery. Follow-up investigations, including CT scans and endoscopy will be performed as per clinician's discretion (as per standard care).
Timepoint [4] 329936 0
2 years from date of surgery
Secondary outcome [5] 330000 0
Correlation of MRI and PET biomarkers with 2 year overall survival
Timepoint [5] 330000 0
2 years from date of surgery.

Eligibility
Key inclusion criteria
1. Age greater than 18
2. Stage II or III rectal adenocarcinoma, defined as T3 - T4 and/or node positive disease (N1-2), without distant metastatic disease (M0)
3. No evidence of metastatic disease on CT chest/abdomen/pelvis
4. Undergoing treatment algorithm consisting of neoadjuvant chemoradiotherapy (radiotherapy 50.4Gy in 28 fractions concurrent with infusional 5-fluorouracil or oral capecitabine) followed by surgery at 6 to 12 weeks post chemoradiotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Other malignancy
2. Active inflammatory bowel disease
3. On concurrent high-dose corticosteroids (the equivalent of 50mg prednisone daily)
4. Inability to have MRI due to:
a. Implanted magnetic metal eg. Intraocular metal
b. Pacemaker / Implantable defibrillator
c. Extreme claustrophobia.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7077 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 7078 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 7079 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 14805 0
2170 - Liverpool
Recruitment postcode(s) [2] 14806 0
2560 - Campbelltown
Recruitment postcode(s) [3] 14807 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 295121 0
Hospital
Name [1] 295121 0
Department of Radiation Oncology, Liverpool Cancer Therapy Centre, Liverpool Hospital
Country [1] 295121 0
Australia
Funding source category [2] 295124 0
Other Collaborative groups
Name [2] 295124 0
Royal Australian and New Zealand College of Radiologists
Country [2] 295124 0
Australia
Primary sponsor type
Individual
Name
Dr Trang Pham
Address
Department of Radiation Oncology
Liverpool Cancer Therapy Centre
Liverpool Hospital
Elizabeth St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 293943 0
None
Name [1] 293943 0
Address [1] 293943 0
Country [1] 293943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296473 0
South Western Sydney Local Health District Human Research and Ethics Committee (HREC)
Ethics committee address [1] 296473 0
Ethics committee country [1] 296473 0
Australia
Date submitted for ethics approval [1] 296473 0
Approval date [1] 296473 0
11/09/2013
Ethics approval number [1] 296473 0
ReferenceHREC/13/LPOOL/158, local project number 13/097a, 13/097b, 13/097c, Substudy Rectal Cancer

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70986 0
Dr Trang Pham
Address 70986 0
Department of Radiation Oncology
Liverpool Cancer Therapy Centre
Liverpool Hospital
Elizabeth St, Liverpool NSW 2170
Country 70986 0
Australia
Phone 70986 0
+612 8738 5180
Fax 70986 0
Email 70986 0
trang.pham@sswahs.nsw.gov.au
Contact person for public queries
Name 70987 0
Trang Pham
Address 70987 0
Department of Radiation Oncology
Liverpool Cancer Therapy Centre
Liverpool Hospital
Elizabeth St, Liverpool NSW 2170
Country 70987 0
Australia
Phone 70987 0
+612 8738 5180
Fax 70987 0
Email 70987 0
trang.pham@sswahs.nsw.gov.au
Contact person for scientific queries
Name 70988 0
Trang Pham
Address 70988 0
Department of Radiation Oncology
Liverpool Cancer Therapy Centre
Liverpool Hospital
Elizabeth St, Liverpool NSW 2170
Country 70988 0
Australia
Phone 70988 0
+612 8738 5180
Fax 70988 0
Email 70988 0
trang.pham@sswahs.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: Multi-parametric magnetic resonance imaging for therapeutic response prediction in rectal cancer.2017https://dx.doi.org/10.1186/s12885-017-3449-4
EmbaseFunctional Imaging Predictors of Response to Chemoradiation.2018https://dx.doi.org/10.1007/s11888-018-0407-8
EmbaseMulti-parametric magnetic resonance imaging assessment of whole tumour heterogeneity for chemoradiotherapy response prediction in rectal cancer.2021https://dx.doi.org/10.1016/j.phro.2021.03.003
N.B. These documents automatically identified may not have been verified by the study sponsor.