Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02233374




Registration number
NCT02233374
Ethics application status
Date submitted
13/08/2014
Date registered
8/09/2014
Date last updated
28/10/2022

Titles & IDs
Public title
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
Scientific title
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
Secondary ID [1] 0 0
14-NSCCRO-P001
Universal Trial Number (UTN)
Trial acronym
PRISM
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Early MRI and PET/CT - 2 weeks after commencing chemo/RT
Other interventions - Late MRI and PET/CT 6 weeks post chemo/RT

Experimental: Assessing response with MRI + PET. - Pre-operative chemo/RT as per standard treatment. Intensity Modulated Radiotherapy (IMRT) / Volumetric Arc Therapy (VMAT) 45Gray/25 fractions with simultaneous integrated Boost of 50Gray/25 fractions + concurrent capecitabine chemotherapy.

Intervention 1 'Early MRI and PET/CT - 2 weeks after commencing chemo/RT' involves additional Multiparametric MRI + PET/CT 2 weeks into chemo/RT Intervention 2 :\\'Late MRI and PET/CT 6 weeks post chemo/RT' involves additional Multiparametric MRI + PET/CT 6 weeks post chemo/RT


Other interventions: Early MRI and PET/CT - 2 weeks after commencing chemo/RT
Patients will have an early MRI and PET/CT - 2 weeks after commencing chemo/RT. A limited range PET/CT will look at parameters: SUVmaxm PERCIST, RECIST 1.1, ?SUV (PET1-2), ?SUV (early -late), Glycolytic tumour volume (GTV). MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will look at parameters: DWI \& ADC value (preferably on a single camera with reproducible ADC value), Local Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.

Other interventions: Late MRI and PET/CT 6 weeks post chemo/RT
Patients will have late a MRI and PET/CT 6 weeks post chemo/RT. A whole body PET/CT will look at parameters: SUVmaxm PERCIST, RECIST 1.1, ?SUV (PET1-2), ?SUV (early -late), Glycolytic tumour volume (GTV). MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will look at parameters: DWI \& ADC value (preferably on a single camera with reproducible ADC value), Local Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Predictive value of PET/CT and MRI 2 weeks into chemo-irradiation for developing a pathologic complete response at surgery.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Feasibility of conducting additional PET and MRI scans at 6 weeks post-treatment.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Utility of adding PET scan to the baseline staging of patients
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Pathologic response according to Tumour Regression Grade (TRG)
Timepoint [3] 0 0
2.5 years
Secondary outcome [4] 0 0
Impact of pCR rates on long term disease control
Timepoint [4] 0 0
5 years

Eligibility
Key inclusion criteria
* Age > 18 years
* T3/4 or node positive rectal cancer
* Suitable for pre-operative chemo-irradiation and surgical resection
* No contraindication to MRI (pacemaker, severe claustrophobia)
* Gross visible disease on MRI
* No contraindications to PET/CT
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky Performance Status > 70%)
* Ability to understand and the willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* - Previous radiotherapy to pelvis
* Unable/unwilling to have MRI
* Unable/unwilling to have PET/CT
* Pregnancy, lactation or inadequate contraception
* Known allergic reaction to FDG PET contrast
* Pacemaker or implanted defibrillator
* Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.
* Unwilling or unable to give informed consent

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate if PET/CT and MRI scans performed early in treatment and six weeks after treatment can predict the response of rectal cancer following chemotherapy and radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.
Trial website
https://clinicaltrials.gov/study/NCT02233374
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Kneebone, MBBS
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02233374