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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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French patients

Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Australians patients

Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

MDT (Multidisciplinary team) meeting observation

3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No