Clinical trial · Observational
Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging) | Other | — | UNRESOLVED |
| MDT (Multidisciplinary team) meeting observation | Other | — | UNRESOLVED |
| Semi-structured exploratory interviews and focus group with MDT health professional attendees | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- French patients
- interventionNames
- 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
- label
- Australians patients
- interventionNames
- 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
Primary outcomes (1)
- measure
- Clinical resection rates in both countries
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDenost 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. PMID 27044252