Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer

Rectal Cancer Clinical Trial

— PELVICARE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551471
• Other study ID #: CHUBX 2014/37
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• 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.
• MDT (Multidisciplinary team) meeting observation
3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).
• 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

Locations

Country	Name	City	State
Australia	Peter Maccallum Cancer centre	Melbourne
Australia	Royal Prince Alfred Hospital Sydney	Sydney
France	Hôpital Saint-André	Bordeaux
France	Hopital Beaujon	Clichy
France	Hopital A.Michallon	Grenoble
France	Centre Oscar Lambret CLCC	Lille
France	Hopital Lyon Sud	Lyon
France	Institut Paoli Calmette	Marseille
France	CLCC Val d'Aurelle	Montpellier
France	Hôpital Saint-Antoine	Paris
France	Hopital Charles Nicolle	Rouen
France	Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Countries where clinical trial is conducted

Australia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Concordance rate of operative decisions between France and Australia	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.	6 months, 12 months
Secondary	R0 resection rate	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	12 months
Secondary	Disease Free Survival		12 months
Secondary	Overall Survival		12 months
Secondary	Post-operative morbidity and mortality rates	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.	30 days
Secondary	Quality of life questionnaire	According to MOS SF-36 score and FACT-C score	6 months, 12 months
Secondary	Stress level score	According to distress thermometer (score range from 0 [no distress] to 10 [extreme distress])	6 months, 12 months
Secondary	Analyses of semi-structured interviews	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)	12 months