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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
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Scientific title
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
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Secondary ID [1]
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14-NSCCRO-P001
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Universal Trial Number (UTN)
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Trial acronym
PRISM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rectal Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Predictive value of PET/CT and MRI 2 weeks into chemo-irradiation for developing a pathologic complete response at surgery.
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Assessment method [1]
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Predictive value of PET/CT and MRI 2 weeks into chemo-irradiation for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen).
The standard grading system employed by pathologists at Royal North Shore Hospital will be used to measure tumour regression. This is the system recommended by the RCPA synoptic report for colorectal cancer, based on Ryan R, Gibbons D, Hyland JMP, et al. Pathological response following long-course neoadjuvant chemoradiotherapy for locally advanced rectal cancer. Histopathology 2005; 47:141-6.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Feasibility of conducting additional PET and MRI scans at 6 weeks post-treatment.
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Assessment method [1]
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This will be assessed in terms of whether PET and MR imaging approximately 6 weeks after chemo-irradiation adds any additional predictive value to imaging performed 2 weeks into treatment.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Utility of adding PET scan to the baseline staging of patients
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Assessment method [2]
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This will be measured by whether PET 2 weeks into treatment (combined with already utilised MRI) can independently predict the likelihood of a pathological complete response at surgery.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Pathologic response according to Tumour Regression Grade (TRG)
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Assessment method [3]
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A scoring system will be developed based on the degree of response from the PET and MRI scan at 2 weeks incorporating tumour shrinkage (PET and MR), reduction in SUV (PET) and reduction in diffusion (MR) that can best predict the "responders" and "non-responders".
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Timepoint [3]
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2.5 years
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Secondary outcome [4]
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Impact of pCR rates on long term disease control
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Assessment method [4]
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Measured in terms of loco-regional or distant recurrence by 3 years.
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Timepoint [4]
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5 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2018
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Northern Sydney Cancer Centre, Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
Royal North Shore Hospital
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02233374
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrew Kneebone, MBBS
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Address
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Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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