Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer (PELVICARE)
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Purpose
| 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 |
- 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.
- 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 |
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
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02551471
| 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 |
| 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 | |
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


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