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Trial registered on ANZCTR


Registration number
ACTRN12620000757910
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
23/07/2020
Date last updated
23/07/2020
Date data sharing statement initially provided
23/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional imaging-guided radiotherapy dose escalation in rectal adenocarcinoma: a feasibility study
Scientific title
Functional imaging-guided radiotherapy dose escalation in rectal adenocarcinoma: a feasibility study
Secondary ID [1] 301310 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FIGURE-rectal
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal cancer 317495 0
Condition category
Condition code
Cancer 315596 315596 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer.

Patients will undergo pre-treatment MRI in the fortnight prior to commencing radiotherapy (+/- chemotherapy). Boost volume will be defined quantitatively according to intratumoural apparent diffusion coefficient (ADC) value. This volume will be targeted for a single-fraction 5-10Gy boost 3-5 days prior to commencing standard radiotherapy (50Gy delivered in 25 fractions).

Treatment will be administered by the Radiation Oncology department at Sunshine Coast University Hospital (SCUH), Birtinya. Each treatment takes approximately 15 minutes per day. Patients will be reviewed once per week by radiation oncology medical staff as per normal practice. Patients will also be asked to complete a quality of life questionnaire at several timepoints prior to, during and following completion of the treatment course, which will take an additional 5-10 minutes on each occasion.
Intervention code [1] 317610 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323833 0
Rate of radiotherapy-related treatment toxicity as per Common Terminology Criteria for Adverse Events v5.0
Timepoint [1] 323833 0
Acute toxicity: throughout and up to 3 months after treatment
Late toxicity: assessed at 3-12 monthly intervals after completion of treatment
Secondary outcome [1] 383009 0
Rate of pathological complete response
Timepoint [1] 383009 0
Histopathological assessment at time of surgery (>8 weeks after completion of radiotherapy)
Secondary outcome [2] 383010 0
Quality of life (assessed with EORTC QLQ-C30 and EORTC QLQ-CR29 questionnaires)
Timepoint [2] 383010 0
Prior to commencing radiotherapy; during week 3 of radiotherapy; during final week of radiotherapy; pre- and post-surgery; then at post-treatment follow-up at 6-12 monthly intervals for up to 36 months.
Secondary outcome [3] 383011 0
Overall survival (from start of treatment to all-cause mortality)
Timepoint [3] 383011 0
Assessed during routine follow-up (3-12 monthly intervals for 36 months)
Secondary outcome [4] 383012 0
Locoregional recurrence-free survival (from start of treatment to clinical or radiological evidence of locoregional recurrence)
Timepoint [4] 383012 0
Assessed during routine follow-up (3-12 monthly intervals for 36 months)
Secondary outcome [5] 383013 0
Disease-free survival (from start of treatment to radiological, clinical or biochemical evidence of local or distant disease recurrence/progression)
Timepoint [5] 383013 0
Assessed during routine follow-up (3-12 monthly intervals for 36 months)
Secondary outcome [6] 383018 0
Surgical morbidity as per review of inpatient notes and surgical follow up notes
Timepoint [6] 383018 0
Assessed from time of surgery to 3 months post-surgery
Secondary outcome [7] 383384 0
Surgical mortality as per review of inpatient notes and surgical follow up notes
Timepoint [7] 383384 0
Assessed from time of surgery to 3 months post-surgery

Eligibility
Key inclusion criteria
- Able to give informed consent
- Histologically-proven primary rectal adenocarcinoma within 0-10cm of anorectal junction on MRI or enteroscopy (T3, T4 or node positive disease with no evidence of metastatic spread (M0) on staging CT-chest/abdomen/pelvis (i.e. stage II/III disease))
- Patient undergoing curative intent neoadjuvant radiotherapy +/- chemotherapy
-- Neoadjuvant radiotherapy must be first component of neoadjuvant therapy (i.e. no induction course)
-- Concurrent chemotherapy can include capecitabine or fluorouracil
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to MRI studies (e.g. significant claustrophobia, incompatible pacemaker/implantable defibrillator, implanted metals)
- Patients receiving total neoadjuvant chemotherapy
- Significant imaging artefact precluding accurate MRI-guided radiotherapy planning (bilateral hip replacement etc.)
- Previous radiotherapy to pelvis
- Other malignancy conferring life expectancy of less than 3 years
- Pregnancy
- Active inflammatory bowel disease
- Prior diagnosis of connective tissue disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive reporting of toxicity, pathological response, quality of life measures. Kaplan-Meier analysis of survival outcomes (at 12, 24 and 36 months).

Recruitment
Recruitment status
Not yet recruiting
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)
QLD
Recruitment hospital [1] 16695 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 30293 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 305747 0
Hospital
Name [1] 305747 0
Sunshine Coast University Hospital
Address [1] 305747 0
6 Doherty St
Birtinya
QLD 4575
Country [1] 305747 0
Australia
Funding source category [2] 305748 0
University
Name [2] 305748 0
University of the Sunshine Coast
Address [2] 305748 0
90 Sippy Downs Drive
Sippy Downs
QLD 4556
Country [2] 305748 0
Australia
Primary sponsor type
Individual
Name
Dr Myo Min
Address
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya, QLD 4575
Country
Australia
Secondary sponsor category [1] 306177 0
Individual
Name [1] 306177 0
Dr Nathan Hearn
Address [1] 306177 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya, QLD 4575
Country [1] 306177 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306022 0
The Prince Charles Hospital HREC
Ethics committee address [1] 306022 0
The Prince Charles Hospital, Building 14, Rode Road, Chermside QLD 4032
Ethics committee country [1] 306022 0
Australia
Date submitted for ethics approval [1] 306022 0
Approval date [1] 306022 0
02/03/2020
Ethics approval number [1] 306022 0
HREA/2020/QPCH/60803

Summary
Brief summary
The aim of this study to assess the feasibility of a diffusion-weighted magnetic resonance imaging (DW-MRI) guided radiotherapy boost for locally advanced rectal cancer.

Who is it for?
Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent neoadjuvant radiotherapy (+/- chemotherapy) may be eligible for this study.

Study details
Participation in this trial will require undergoing an additional MRI scan prior to starting treatment; one extra day of treatment prior to the usual 5-6 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment.
A key part of the study is also to assess any treatment-related toxicity and your quality of life during and after treatment to ensure the additional dose does not have any adverse effects.
It is hoped that this research will help to improve proportion of patients that completely respond to radiation treatment given with concurrent chemotherapy and therefore reduce the need for surgery for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102450 0
Dr Myo Min
Address 102450 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
Country 102450 0
Australia
Phone 102450 0
+61 7 5202 1111
Fax 102450 0
Email 102450 0
myo.min@health.qld.gov.au
Contact person for public queries
Name 102451 0
Dr Nathan Hearn
Address 102451 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
Country 102451 0
Australia
Phone 102451 0
+61 7 5202 1111
Fax 102451 0
Email 102451 0
nathan.hearn@health.qld.gov.au
Contact person for scientific queries
Name 102452 0
Dr Nathan Hearn
Address 102452 0
Adem Crosby Centre
Sunshine Coast University Hospital
Birtinya QLD 4575
Country 102452 0
Australia
Phone 102452 0
+61 7 5202 1111
Fax 102452 0
Email 102452 0
nathan.hearn@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For confidentiality reasons
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7973 0
Informed consent form
Citation [1] 7973 0
Link [1] 7973 0
Email [1] 7973 0
Other [1] 7973 0
The consent form will be available from the study investigators upon email request to the study contact person or principal investigator, via the contact details listed in the ANZCTR registration record
Attachment [1] 7973 0
Summary results
No Results