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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT02551471
First received: August 31, 2015
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Rectal Cancer Other: Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging) Other: MDT (Multidisciplinary team) meeting observation Other: Semi-structured exploratory interviews and focus group with MDT health professional attendees

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Clinical resection rates in both countries [ Time Frame: 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:
  • Concordance rate of operative decisions between France and Australia [ Time Frame: 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.

  • R0 resection rate [ Time Frame: 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

  • Disease Free Survival [ Time Frame: 12 months ]
  • Overall Survival [ Time Frame: 12 months ]
  • Post-operative morbidity and mortality rates [ Time Frame: 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 [ Time Frame: 6 months, 12 months ]
    According to MOS SF-36 score and FACT-C score

  • Stress level score [ Time Frame: 6 months, 12 months ]
    According to distress thermometer (score range from 0 [no distress] to 10 [extreme distress])

  • Analyses of semi-structured interviews [ Time Frame: 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)


Estimated Enrollment: 240
Study Start Date: May 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
French patients 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.
Other: MDT (Multidisciplinary team) meeting observation
3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).
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
Australians patients 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.
Other: MDT (Multidisciplinary team) meeting observation
3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading).
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02551471

Contacts
Contact: Quentin DENOST, MD +33 (0) 5 56 79 58 10 quentin.denost@chu-bordeaux.fr
Contact: Hélène MAILLOU-MARTINAUD +33 (0 )5 57 82 16 58 helene.maillou-martinaud@chu-bordeaux.fr

Locations
Australia
Peter Maccallum Cancer centre Not yet recruiting
Melbourne, Australia, VIC 3002
Contact: Sandy HERIOT, MD    +61 39656 1111    alexander.heriot@petermac.org   
Royal Prince Alfred Hospital Sydney Recruiting
Sydney, Australia, NSW 2050
Contact: Michael SOLOMON, MD    +61 396 561111    professor.solomon@sydney.edu.au   
France
Hôpital Saint-André Recruiting
Bordeaux, France, 33000
Contact: Quentin DENOST, MD    +33 (0)5 56 79 58 10    quentin.denost@chu-bordeaux.fr   
Contact: Hélène MAILLOU-MARTINAUD    +33 (0)5 57 82 16 58    helene.maillou-martinaud@chu-bordeaux.fr   
Principal Investigator: Quentin DENOST, MD         
Hopital Beaujon Recruiting
Clichy, France, 92110
Contact: Yves PANIS, MD    +33 (0)1 40 87 45 47    yves.panis@bjn.aphp.fr   
Hopital A.Michallon Recruiting
Grenoble, France, 38000
Contact: Jean-Luc FAUCHERON, MD    +33 (0)4 76 76 55 26    jlfaucheron@chu-grenoble.fr   
Centre Oscar Lambret CLCC Recruiting
Lille, France, 59000
Contact: Mehradad JAFARI, MD    +33 (0)3 20 29 59 20    m-jafari@o-lambret.fr   
Hopital Lyon Sud Recruiting
Lyon, France, 69000
Contact: Eddy COTTE, MD    +33 (0)4 78 86 13 85    eddy.cotte@chu-lyon.fr   
Institut Paoli Calmette Recruiting
Marseille, France, 13000
Contact: Bernard LELONG, MD    +33 (0)4 91 22 36 60    lelongb@marseille.fnclcc.fr   
CLCC Val d'Aurelle Recruiting
Montpellier, France, 34000
Contact: Philippe ROUANET, MD    +33 (0)4 67 61 30 71    phillipe.rouanet@montpellier.unicancer.fr   
Hôpital Saint-Antoine Recruiting
Paris, France, 75012
Contact: Jeremie LEFEVRE, MD    +33 (0)1 49 28 25 63    jeremie.lefevre@sat.aphp.fr   
Hopital Charles Nicolle Not yet recruiting
Rouen, France, 76031
Contact: Jean-Jacques TUECH, MD    +33 (0)2 32 88 81 42    jean-jacques.tuech@chu-rouen.fr   
Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Guillaime PORTIER, MD    +33 (0)5 61 77 25 30    portier.g@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02551471     History of Changes
Other Study ID Numbers: CHUBX 2014/37
Study First Received: August 31, 2015
Last Updated: June 27, 2016

Keywords provided by University Hospital, Bordeaux:
Locally advanced rectal cancer
Fixed primary rectal cancer
Pelvic recurrence
Benchmarking France Australia

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 17, 2017