Rectal CancerPELVICARENCT02551471
Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
An observational study of Rectal Cancer, run by University Hospital, Bordeaux at 12 sites in 2 countries.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging), MDT (Multidisciplinary team) meeting observation and Semi-structured exploratory interviews and focus group with MDT health professional attendees
- How many people
- 165 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 1 May 2015to Jul 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France10 sites
Hôpital Saint-André
Bordeaux, 33000
Hopital Beaujon
Clichy, 92110
Hopital A.Michallon
Grenoble, 38000
Centre Oscar Lambret CLCC
Lille, 59000
Hopital Lyon Sud
Lyon, 69000
Institut Paoli Calmette
Marseille, 13000
CLCC Val d'Aurelle
Montpellier, 34000
Hôpital Saint-Antoine
Paris, 75012
Hopital Charles Nicolle
Rouen, 76031
Hôpital Purpan
Toulouse, 31059
Australia2 sites
Peter Maccallum Cancer centre
Melbourne, VIC 3002
Royal Prince Alfred Hospital Sydney
Sydney, NSW 2050
About this study
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging), MDT (Multidisciplinary team) meeting observation, Semi-structured exploratory interviews and focus group with MDT health professional attendees
- Keywords
- Locally advanced rectal cancer, Fixed primary rectal cancer, Pelvic recurrence, Benchmarking France Australia
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)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 observationOther
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 attendeesOther
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
| Study group | Role | What they receive |
|---|---|---|
| French patients | Not described Receives: 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 | |
| Australians patients | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 6 months, 12 months
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
Measured: 12 months
Disease Free Survival
Measured: 12 months
Overall Survival
Measured: 12 months
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.
Measured: 30 days
Quality of life questionnaire
According to MOS SF-36 score and FACT-C score
Measured: 6 months, 12 months
Stress level score
According to distress thermometer (score range from 0 [no distress] to 10 [extreme distress])
Measured: 6 months, 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study start1 May 2015
- Primary completion4 May 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551471
- Sponsor's protocol ID
- CHUBX 2014/37
- Acronym
- PELVICARE
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2015
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27044252
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT02551471
- Acronym / sponsor ID
- PELVICARE / CHUBX 2014/37
- Conditions
- Rectal Cancer
- Keywords
- Locally advanced rectal cancer, Fixed primary rectal cancer, Pelvic recurrence, Benchmarking France Australia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| French patients | – | 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 |
| Australians patients | – | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Australians patients, French patients |
| MDT (Multidisciplinary team) meeting observation3 per centre with "real" patient cases and "theoretical" patient cases (blinded pelvic MRI re-reading). | Other | Australians patients, French patients |
| Semi-structured exploratory interviews and focus group with MDT health professional attendeesWill 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 | Other | Australians patients, French patients |
Primary outcome
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.
8 secondary outcomes
Concordance rate of operative decisions between France and Australia
Time frame: 6 months, 12 months
R0 resection rate
Time frame: 12 months
Disease Free Survival
Time frame: 12 months
Overall Survival
Time frame: 12 months
Post-operative morbidity and mortality rates
Time frame: 30 days
Quality of life questionnaire
Time frame: 6 months, 12 months
Stress level score
Time frame: 6 months, 12 months
Analyses of semi-structured interviews
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 27044252Denost 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University Hospital, Bordeaux at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical resection rates in both countries (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.