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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02233374