Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
PELVICARE
1 other identifier
observational
165
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedAugust 9, 2018
August 1, 2018
3 years
August 31, 2015
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical resection rates in both countries
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.
12 months
Secondary Outcomes (8)
Concordance rate of operative decisions between France and Australia
6 months, 12 months
R0 resection rate
12 months
Disease Free Survival
12 months
Overall Survival
12 months
Post-operative morbidity and mortality rates
30 days
- +3 more secondary outcomes
Study Arms (2)
French patients
Australians patients
Interventions
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).
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Peter Maccallum Cancer centre
Melbourne, VIC 3002, Australia
Royal Prince Alfred Hospital Sydney
Sydney, NSW 2050, Australia
Hôpital Saint-André
Bordeaux, 33000, France
Hopital Beaujon
Clichy, 92110, France
Hopital A.Michallon
Grenoble, 38000, France
Centre Oscar Lambret CLCC
Lille, 59000, France
Hopital Lyon Sud
Lyon, 69000, France
Institut Paoli Calmette
Marseille, 13000, France
CLCC Val d'Aurelle
Montpellier, 34000, France
Hôpital Saint-Antoine
Paris, 75012, France
Hopital Charles Nicolle
Rouen, 76031, France
Hôpital Purpan
Toulouse, 31059, France
Related Publications (1)
Denost Q, Saillour F, Masya L, Martinaud HM, Guillon S, Kret M, Rullier E, Quintard B, Solomon M. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design. BMC Cancer. 2016 Apr 4;16:262. doi: 10.1186/s12885-016-2286-1.
PMID: 27044252DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 16, 2015
Study Start
May 1, 2015
Primary Completion
May 4, 2018
Study Completion
July 1, 2018
Last Updated
August 9, 2018
Record last verified: 2018-08