Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
- Conditions
- Rectal Cancer
- Interventions
- Other: Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)Other: MDT (Multidisciplinary team) meeting observationOther: Semi-structured exploratory interviews and focus group with MDT health professional attendees
- Registration Number
- NCT02551471
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Australians patients Semi-structured exploratory interviews and focus group with MDT health professional attendees - French patients MDT (Multidisciplinary team) meeting observation - French patients Semi-structured exploratory interviews and focus group with MDT health professional attendees - Australians patients MDT (Multidisciplinary team) meeting observation - French patients Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging) - Australians patients Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging) -
- Primary Outcome Measures
Name Time Method Clinical resection rates in both countries 12 months 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.
- Secondary Outcome Measures
Name Time Method R0 resection rate 12 months 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
Concordance rate of operative decisions between France and Australia 6 months, 12 months 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.
Disease Free Survival 12 months Overall Survival 12 months Analyses of semi-structured interviews 12 months 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)
Post-operative morbidity and mortality rates 30 days 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.
Quality of life questionnaire 6 months, 12 months According to MOS SF-36 score and FACT-C score
Stress level score 6 months, 12 months According to distress thermometer (score range from 0 \[no distress\] to 10 \[extreme distress\])
Trial Locations
- Locations (12)
Hopital Beaujon
🇫🇷Clichy, France
Centre Oscar Lambret CLCC
🇫🇷Lille, France
Hôpital Saint-André
🇫🇷Bordeaux, France
Royal Prince Alfred Hospital Sydney
🇦🇺Sydney, Australia
Peter Maccallum Cancer centre
🇦🇺Melbourne, Australia
CLCC Val d'Aurelle
🇫🇷Montpellier, France
Hôpital Saint-Antoine
🇫🇷Paris, France
Hopital A.Michallon
🇫🇷Grenoble, France
Hopital Lyon Sud
🇫🇷Lyon, France
Institut Paoli Calmette
🇫🇷Marseille, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Hôpital Purpan
🇫🇷Toulouse, France