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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02551471
Registration number
NCT02551471
Ethics application status
Date submitted
31/08/2015
Date registered
16/09/2015
Date last updated
9/08/2018
Titles & IDs
Public title
Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
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Scientific title
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Secondary ID [1]
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CHUBX 2014/37
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Universal Trial Number (UTN)
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Trial acronym
PELVICARE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer
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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
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)
Other interventions - MDT (Multidisciplinary team) meeting observation
Other interventions - Semi-structured exploratory interviews and focus group with MDT health professional attendees
French patients -
Australians patients -
Other interventions: Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)
This experiment will consist of an inter-country reading of patients' pelvic MRIs, "blind" to the other country's decision. The MRI shared will be the one based on which the treatment decision will be made. In case of medical contraindication to perform pelvic MRI, the scan will be used to assess the care-decision concordance between both countries.
Other interventions: MDT (Multidisciplinary team) meeting observation
3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).
Other interventions: Semi-structured exploratory interviews and focus group with MDT health professional attendees
Will identify care management systems for PRC-bTME and LRRC patients, explore social representations that direct the formulation of a therapeutic decisions and identify cultural, medical and personal factors
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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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Clinical resection rates in both countries
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Assessment method [1]
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Expressed as a percentage and corresponding to the ratio between the number of patients operated and the number of patients discussed in colorectal MDT meetings for PRC-bTME and LRRC. These rates will be expressed separately in each country and compared.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Concordance rate of operative decisions between France and Australia
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Assessment method [1]
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An analysis of concordance between French and Australian operative decisions will be carried out through the radiological (or theoretical) resectability rate, expressed as a percentage and corresponding, after blind inter-country reading of pelvic MRIs, to the ratio between the number of patients judged to have resectable tumours and the number of all MRI re-reading.
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Timepoint [1]
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6 months, 12 months
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Secondary outcome [2]
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R0 resection rate
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Assessment method [2]
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Expressed as a percentage and corresponding to the report of the number of patients operated with a surgical resection margin > 1mm on the number of operated patients
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Disease Free Survival
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Assessment method [3]
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Post-operative morbidity and mortality rates
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Assessment method [5]
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Evaluated according to the Dindo scale for patients in curative intent treatment. Grade I was any deviation from the normal postoperative course, Grade II included pharmacological treatment, Grade III was complications requiring surgical, endoscopic or radiological intervention, Grade IV included life-threatening complications requiring intensive care unit management and Grade V complications caused postoperative death.
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Timepoint [5]
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30 days
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Secondary outcome [6]
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Quality of life questionnaire
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Assessment method [6]
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According to MOS SF-36 score and FACT-C score
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Timepoint [6]
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6 months, 12 months
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Secondary outcome [7]
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Stress level score
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Assessment method [7]
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According to distress thermometer (score range from 0 [no distress] to 10 [extreme distress])
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Timepoint [7]
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6 months, 12 months
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Secondary outcome [8]
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Analyses of semi-structured interviews
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Assessment method [8]
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Occurrence and cooccurrence computation of thematic contents (frequency and Chi square analyses) ; similarity analyses (maximum three with connectedness and similarity index computations, identification of the central and peripheral representation cores in each occupational group)
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Timepoint [8]
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12 months
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Eligibility
Key inclusion criteria
- Patients operable and/or capable of receiving a radiotherapy and/or a chemotherapy
- Patients in care in the French and Australian centres participating in the study
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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
- Patients suffering from primitive rectal cancer at a stage inferior to T4b
- Patients suffering from primitive locally-advanced metastatic rectal cancer (T4NxM1)
- Patients suffering from recurrence of metastatic rectal cancer
- Patients having been refused a surgical procedure because of one or multiple
comorbidities
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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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
1/05/2015
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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
1/07/2018
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Sample size
Target
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Accrual to date
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Final
165
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter Maccallum Cancer centre - Melbourne
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Recruitment hospital [2]
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Royal Prince Alfred Hospital Sydney - Sydney
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Recruitment postcode(s) [1]
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VIC 3002 - Melbourne
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Recruitment postcode(s) [2]
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NSW 2050 - Sydney
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
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Bordeaux
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Country [2]
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France
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State/province [2]
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Clichy
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Country [3]
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France
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State/province [3]
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Grenoble
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Country [4]
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France
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State/province [4]
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Lille
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Country [5]
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France
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State/province [5]
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Lyon
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Country [6]
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France
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State/province [6]
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Marseille
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Country [7]
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France
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State/province [7]
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Montpellier
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Country [8]
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France
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State/province [8]
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Paris
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Country [9]
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France
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State/province [9]
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Rouen
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Country [10]
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France
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State/province [10]
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Toulouse
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital, Bordeaux
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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 incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15%
are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection
margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The
invasion of the resection margins triples the risk of local recurrence. In the absence of
surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of
rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative
resection. The care and management of locally advanced and fixed rectal tumours and pelvic
recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a
difficult therapeutic problem with great variability in the methods of care and management
around the world. These variations in practice can be explained by structural and
organizational differences, as well as cultural dissimilarities. With regards to the
organization of its healthcare system, Australia is shown to be a leader as regards the care
and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal
cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02551471
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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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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 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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02551471
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