- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551471
Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer (PELVICARE)
Study Overview
Status
Conditions
Detailed Description
This research project rests on the comparison between two contrasting countries with regards to the care management of PRC-bTME (Primary rectal cancer beyond total mesorectum excision planes) and LRRC (Locally recurrent rectal cancer), France and Australia. Regarding its healthcare system for patients with PRC-bTME and LRRC, Australia equipped itself with a veritable policy of centralisation and clinical pathway, appearing as an international referent country in this surgical field.
The main hypotheses of research are that these differences rest on individual and collective representation of disease, organisations, structures, clinical pathway and care management.
Benchmarking of clinical practices is a process that consists of a structured comparison and the sharing of good practices of clinical care; it is based on a quality of care assessment and allows to fit into an approach of continuous improvement of this quality of care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Melbourne, Australia, VIC 3002
- Peter MacCallum Cancer Centre
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Sydney, Australia, NSW 2050
- Royal Prince Alfred Hospital Sydney
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Bordeaux, France, 33000
- Hôpital Saint-André
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Clichy, France, 92110
- Hopital Beaujon
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Grenoble, France, 38000
- Hôpital A.Michallon
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Lille, France, 59000
- Centre Oscar Lambret CLCC
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Lyon, France, 69000
- Hopital Lyon Sud
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Marseille, France, 13000
- Institut Paoli Calmette
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Montpellier, France, 34000
- CLCC Val d'Aurelle
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Paris, France, 75012
- Hopital Saint-Antoine
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Rouen, France, 76031
- Hopital Charles Nicolle
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Toulouse, France, 31059
- Hopital Purpan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients suffering from primitive locally-advanced non-metastatic rectal cancer (T4bNxM0), operated and non-operated.
Patients suffering from non-metastatic recurrence of rectal cancer, operated and non-operated
Description
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
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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French patients
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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.
3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).
Other: 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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Australians patients
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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.
3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).
Other: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Clinical resection rates in both countries
Time Frame: 12 months
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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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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Concordance rate of operative decisions between France and Australia
Time Frame: 6 months, 12 months
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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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6 months, 12 months
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R0 resection rate
Time Frame: 12 months
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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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12 months
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Disease Free Survival
Time Frame: 12 months
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12 months
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Overall Survival
Time Frame: 12 months
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12 months
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Post-operative morbidity and mortality rates
Time Frame: 30 days
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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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30 days
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Quality of life questionnaire
Time Frame: 6 months, 12 months
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According to MOS SF-36 score and FACT-C score
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6 months, 12 months
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Stress level score
Time Frame: 6 months, 12 months
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According to distress thermometer (score range from 0 [no distress] to 10 [extreme distress])
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6 months, 12 months
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Analyses of semi-structured interviews
Time Frame: 12 months
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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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12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2014/37
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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