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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Locally advanced rectal cancer
Fixed primary rectal cancer
Pelvic recurrence
Benchmarking France Australia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical resection rates in both countries
timeFrame: 12 months
Secondary outcomes:
measure: Concordance rate of operative decisions between France and Australia
timeFrame: 6 months, 12 months
measure: R0 resection rate
timeFrame: 12 months
measure: Disease Free Survival
timeFrame: 12 months
measure: Overall Survival
timeFrame: 12 months
measure: Post-operative morbidity and mortality rates
timeFrame: 30 days
measure: Quality of life questionnaire
timeFrame: 6 months, 12 months
measure: Stress level score
timeFrame: 6 months, 12 months
measure: Analyses of semi-structured interviews
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer centre
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital Sydney
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Clichy
country: France
facility: Hopital Beaujon
city: Grenoble
country: France
facility: Hopital A.Michallon
city: Lille
country: France
facility: Centre Oscar Lambret CLCC
city: Lyon
country: France
facility: Hopital Lyon Sud
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: CLCC Val d'Aurelle
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
References:
citation: 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.