Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001005448
Ethics application status
Approved
Date submitted
19/08/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Date data sharing statement initially provided
10/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional imaging-guided radiotherapy short course dose escalation in rectal adenocarcinoma: a feasibility study
Scientific title
Functional imaging-guided radiotherapy short course dose escalation in rectal adenocarcinoma: a feasibility study
Secondary ID [1] 315168 0
None
Universal Trial Number (UTN)
Trial acronym
FIGR-Short
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal cancer 338601 0
Condition category
Condition code
Cancer 334903 334903 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will utilise a single-arm prospective design to evaluate the feasibility of a radiation boost dose using functional imaging data in a cohort of 15-30 locally advanced rectal cancer patients recruited across 18-36 months at Sunshine Coast University Hospital (SCUH).

Pre-treatment diffusion weighted magnetic resonance imaging (DW-MRI) scans will be used to delineate the hypercellular regions within the gross tumour volume (GTV) for the radiation boost dose. The pre-treatment DW-MRI scan will be performed approximately 2 weeks prior to the radiation boost dose. The radiation boost dose will be delivered in a single radiotherapy session only, with this session taking approximately 30-45 minutes. Specifically, these regions will receive an additional fraction of 5-10Gy within 14 days prior to commencing standard short course radiation therapy (SCRT) (25Gy in 5 fractions).

The study will start with a 5Gy boost for the first 5-10 patients, then an interim safety analysis will be performed. The next 5-10 patients will receive a 7Gy boost with another interim safety analysis, then the final 5-10 patients will receive a 10Gy boost. The dose for any patient may be reduced to the previously given radiation dose level if deemed necessary to meet organ at risk dose constraints for any given patient.

Adherence will be monitored by checking the electronic medical record (MOSAIQ software) for the recorded treatment.
Intervention code [1] 331784 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342527 0
To prospectively assess the feasibility of administrating a radiotherapy boost dose to a DW-MRI defined sub volume in locally advanced rectal cancer radiotherapy patients while meeting standard treatment dose constraints.
Timepoint [1] 342527 0
At time of Radiation Oncologist plan approval and after successful treatment delivery of the boost dose treatment.
Primary outcome [2] 342528 0
To determine the effect on treatment-related toxicities following the radiotherapy boost dose.
Timepoint [2] 342528 0
Baseline prior to single fraction boost dose, prior to standard 25Gy/5 fractions short course radiotherapy treatment, after fraction 4 or 5 of short course radiotherapy treatment, 2-4 weeks after radiotherapy treatment (prior to surgery/chemotherapy) and 3, 6, 12, 24 and 36 months after radiotherapy treatment.
Secondary outcome [1] 451170 0
To evaluate patient quality of life via patient reported outcome measures (PROMs)
Timepoint [1] 451170 0
Baseline prior to single fraction boost dose, after fraction 4 or 5 of short course radiotherapy treatment, 2-4 weeks after radiotherapy treatment (prior to surgery/chemotherapy) and 3, 6, 12, 24 and 36 months after radiotherapy treatment.
Secondary outcome [2] 451171 0
To evaluate clinical complete response rate (cCR)
Timepoint [2] 451171 0
As per standard of care, typically around 12 months after radiotherapy treatment.
Secondary outcome [3] 451172 0
To evaluate grade of histopathological response, including pathological complete response rate (pCR). Assessed as a composite secondary outcome.
Timepoint [3] 451172 0
As per standard of care, typically 4-8 weeks after short course radiotherapy, however this may be longer if patient has chemotherapy following short course radiotherapy.
Secondary outcome [4] 451173 0
To assess locoregional failure-free survival
Timepoint [4] 451173 0
3, 6, 12, 24 and 36 months after radiotherapy
Secondary outcome [5] 451174 0
To assess disease-free survival
Timepoint [5] 451174 0
3, 6, 12, 24 and 36 months after radiotherapy

Eligibility
Key inclusion criteria
- 18 years or older
- Able to give informed consent
- Histologically-proven primary rectal adenocarcinoma within 0-10cm of anorectal junction or below the peritoneal reflection 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 recommended at colorectal multidisciplinary team meeting to undergo curative intent neoadjuvant short course radiotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindication to MRI studies o Significant claustrophobia o Pacemaker/implantable defibrillator o Implanted metals
- Significant imaging artefact precluding accurate MRI-guided radiotherapy planning (bilateral hip replacement etc.)
- Previous radiotherapy to pelvis
- Participation in another rectal cancer treatment related clinical trial
- Other malignancy/comorbidity conferring life expectancy of less than 1 year
- 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)
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
- Statistical analysis will be performed using IBM SPSS Statistics software and R Statistics.
Statistical significance will be defined for p < 0.05 (two-tailed).
- Population demographic statistics will be descriptively reported
- Rates of histopathological response (pCR) or clinical response (cCR) will be descriptively reported and compared with historical reports
- Toxicity rates, surgical complication rates and PROMs will be descriptively reported and compared with historical reports.
- Rates of locoregional recurrence and disease-free survival will be assessed with Kaplan-Meier survival curves.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2025
Actual
Date of last participant enrolment
Anticipated
15/09/2028
Actual
Date of last data collection
Anticipated
17/11/2031
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28346 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 44564 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 319742 0
Hospital
Name [1] 319742 0
Sunshine Coast University Hospital
Country [1] 319742 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
Country
Australia
Secondary sponsor category [1] 322248 0
None
Name [1] 322248 0
Address [1] 322248 0
Country [1] 322248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318293 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 318293 0
Ethics committee country [1] 318293 0
Australia
Date submitted for ethics approval [1] 318293 0
12/09/2024
Approval date [1] 318293 0
20/11/2024
Ethics approval number [1] 318293 0
HREC/2024/QGC/110683

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

Contacts
Principal investigator
Name 143730 0
Dr Dinesh Vignarajah
Address 143730 0
Sunshine Coast University Hospital, 6 Doherty Street Birtinya QLD 4575
Country 143730 0
Australia
Phone 143730 0
+61 07 5202 8257
Fax 143730 0
Email 143730 0
[email protected]
Contact person for public queries
Name 143731 0
Claire Filet
Address 143731 0
Sunshine Coast University Hospital, 6 Doherty Street Birtinya QLD 4575
Country 143731 0
Australia
Phone 143731 0
+61 07 5202 0651
Fax 143731 0
Email 143731 0
[email protected]
Contact person for scientific queries
Name 143732 0
Dr Dinesh Vignarajah
Address 143732 0
Sunshine Coast University Hospital, 6 Doherty Street Birtinya QLD 4575
Country 143732 0
Australia
Phone 143732 0
+61 07 5202 8257
Fax 143732 0
Email 143732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Participants in the study have an option to request study results on the participant information and consent form by providing their email. Other requests will be considered on a case by case basis. All individual participant data will be de-identified prior to sharing.

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
Participants will be able to request as they join the trial by providing their email address on the participant information and consent form. Other requests may happen at the end of the study.

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Requests can be made through the emails provided in the contacts section of this trial registry.

Are there extra considerations when requesting access to individual participant data?
Yes: Any extra considerations will be considered upon requesting access to the data. These may include response time and departmental policies.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    The consent form will be available from the study ... [More Details]


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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