Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design

Quentin Denost, Florence Saillour, Lindy Masya, Helene Maillou Martinaud, Stephanie Guillon, Marion Kret, Eric Rullier, Bruno Quintard, Michael Solomon, Quentin Denost, Florence Saillour, Lindy Masya, Helene Maillou Martinaud, Stephanie Guillon, Marion Kret, Eric Rullier, Bruno Quintard, Michael Solomon

Abstract

Background: Among patients with rectal cancer, 5-10% have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10% recur locally following primary surgery (LRRC). In both cases, patients 'care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients' care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients.

Methods/design: The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end points will be concordance rate between French and Australian operative decisions based on the inter-country reading MRI, post-operative mortality and morbidity rates, oncological outcomes based on resection status and one-year overall and disease-free survival, patients' quality of life and distress level. Qualitative analysis will compare obstacles and facilitators of operative decision-making between both countries.

Discussion: Benchmarking can be defined as a comparison and learning process which will allow, in the context of PRC-bTME and LRRC, to understand and to share the whole process management of these patientsbetween Farnce and Australia.

Trial registration: NCT02551471 . (date of registration: 09/14/2015).

Keywords: Benchmarking study; Clinical pathway; Locally recurrent rectal cancer (LRRC); Operative decision-making; Primary rectal cancer beyond total mesorectal excision plane (PRC-bTME).

Figures

Fig. 1
Fig. 1
Flow chart PelviCare trial

References

    1. Beyond TME Collaborative Consensus statement on the multidisciplinary management of patients with recurrent and primary rectal cancer beyond total mesorectal excision planes. Br J Surg. 2013;100:1009–1014. doi: 10.1002/bjs.9192.
    1. Hida J, Yasutomi M, Maruyama T, Nakajima A, Uchida T, Wakano T, et al. Results from pelvic exenteration for locally advanced colorectal cancer with lymph node metastases. Dis Colon Rectum. 1998;41:165–8. doi: 10.1007/BF02238243.
    1. Braendengen M, Tveit KM, Berglund A, Birkemeyer E, Frykholm G, Påhlman L, Wiig JN, Byström P, Bujko K, Glimelius B. Randomized phase III study comparing preoperative radiotherapy with chemoradiotherapy in nonresectable rectal cancer. J Clin Oncol. 2008;26(22):3687–94. doi: 10.1200/JCO.2007.15.3858.
    1. Van Gijn W, Dutch colorectal cancer group Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicenter, randomized controlled TME trial. Lancet Oncol. 2011;12(6):575–82. doi: 10.1016/S1470-2045(11)70097-3.
    1. Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ. Five-year follow-up of the Medical Research Coucil CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer. Br J Surg. 2010;97:1638–1645. doi: 10.1002/bjs.7160.
    1. Suzuki K, Dozois RR, Devine RM, Nelson H, Weaver AL, Gunderson LL, Ilstrup DM. Curative reoperations for locally recurrent rectal cancer. Dis Colon Rectum. 1996;39:730–6. doi: 10.1007/BF02054435.
    1. Lopez-Kostner F, Fazio VW, Vignali A, Rybicki LA, Lavery IC. Locally recurrent rectal cancer : Predictors and success of salvage surgery. Dis Colon Rectum. 2001;44:173–8. doi: 10.1007/BF02234289.
    1. Salo JC, Paty PB, Guillem J, Minsky BD, Harrison LB, Cohen AM. Surgical salvage of recurrent rectal carcinoma after curative resection : A 10-year experience. Ann Surg Oncol. 1999;6:171–7. doi: 10.1007/s10434-999-0171-8.
    1. Boyle KM, Sagar PM, Chalmers AG, Sebag-Montefiore D, Cairns A, Eardley I. Surgery for locally recurrent rectal cancer. Dis Colon Rectum. 2005;48:929–37. doi: 10.1007/s10350-004-0909-0.
    1. Hahnloser D, Nelson H, Gunderson LL, Hassan I, Haddock MG, O’Connell MJ, Cha S, Sargent DJ, Horgan A. Curative potential of multimodality therapy for locally recurrent rcetal cancer. Ann Surg. 2003;4:502–8.
    1. Heald RJ, Moran BJ, Ryall RDH, Sexton R, McFarlane JK. Rectal cancer. The Basingstoke experience of total mesorectal excision, 1987–1997. Arch Surg. 1998;133:894–899. doi: 10.1001/archsurg.133.8.894.
    1. Nakafusa Y, Tanaka T, Tanaka M, Kitajima Y, Sato S, Miyazaki K. Comparison of multivisceral resection and standard operation for locally advanced colorectal cancer: analysis of prognostic factors for short-term and long-term outcome. Dis Colon Rectum. 2004;47(12):2055–63. doi: 10.1007/s10350-004-0716-7.
    1. Hoffmann M, Phillips C, Oevermann E, Killaitis C, Roblick UJ, Hildebrand P, Buerk CG, Wolken H, Kujath P, Schloericke E, Bruch HP. Multivisceral and standard resections in colorectal cancer. Langenbecks Arch Surg. 2012;397(1):75–84. doi: 10.1007/s00423-011-0854-z.
    1. Mohan HM, Evans MD, Larkin JO, Beynon J, Winter DC. Multivisceral resection in colorectal cancer: a systematic review. Ann Surg Oncol. 2013;20(9):2929–36. doi: 10.1245/s10434-013-2967-9.
    1. Hansen MH, Balteskard L, Dørum LM, Eriksen MT, Vonen B, Norwegian Colorectal Cancer Group Locally recurrent rectal cancer in Norway. Br J Surg. 2009;96(10):1176–82. doi: 10.1002/bjs.6699.
    1. Bhangu A, Ali SM, Cunningham D, Brown G, Tekkis P. Comparison of long-term survival outcome of operative vs nonoperative management of recurrent rectal cancer. Colorectal Dis. 2013;15(2):156–63. doi: 10.1111/j.1463-1318.2012.03123.x.
    1. McDermott FT, Hughes ESR, Pihl E, Johnson WJR, Price AB. Local recurrence after potentially curative resection for rectal cancer in a series of 1 008 patients. Br J Surg. 1985;72:34–37. doi: 10.1002/bjs.1800720115.
    1. Yang TX, Morris DL, Chua TC. Pelvic exenteration for rectal cancer: a systematic review. Dis Colon Rectum. 2013;56(4):519–31. doi: 10.1097/DCR.0b013e31827a7868.
    1. Edge S, Compton C. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010;17:1471–1474. doi: 10.1245/s10434-010-0985-4.
    1. Hari DM, Bilchik AJ. Clinical decision-making and implementation challenges with the AJCC VII staging system for colorectal carcinoma. J Surg Oncology. 2012;105:221–222. doi: 10.1002/jso.22086.
    1. Kim KH, Yang SS, Yoon YS, Lim SB, Yu CS, Kim JC. Validation of the seventh edition of the American Joint Committee on Cancer Tumor-Node-Metastasis (AJCC TNM) staging in patients with stage II and stage III colorectal carcinoma: analysis of 2511 cases from a medical centre in Korea. Colorectal Dis. 2011;13(8):e220–6. doi: 10.1111/j.1463-1318.2011.02625.x.
    1. NSW Health on behalf of the nationally funded centres reference group . Report on health technology assessment of a proposal to establish a pelvic exenteration procedure as a nationally funded centre. 2012.
    1. Gérard A, Duyse M, Nordlinger B, Loygue J, Pène F, Kempf P, et al. Preoperative radiotherapy as adjuvant treatment in rectal cancer. Final results of a randomized study of the European Organization for Research and Treatment of Cancer. Ann Surg. 1988;208:606–614. doi: 10.1097/00000658-198811000-00011.
    1. Heriot AG, Tekkis PP, Darzi A, Mackay J. Surgery for local recurrence or rectal cancer. Colorectal Dis. 2006;8(9):733–47. doi: 10.1111/j.1463-1318.2006.01018.x.
    1. Heriot AG, Byrne C, Lee P, Dobbs B, Tilney H, Solomon MJ, Mackay J, Frizelle F. Extended radical resection: the choice for locally recurrent rectal cancer. Dis Colon Rectum. 2008;51:284–291. doi: 10.1007/s10350-007-9152-9.
    1. Yamada K, Ishizawa T, Niwa K, Chuman Y, Akiba S, Aikou T. Patterns of pelvic invasion are prognostic in the treatment of locally recurrent rectal cancer. Br J Surg. 2001;88(7):988–93. doi: 10.1046/j.0007-1323.2001.01811.x.
    1. Wanebo HJ, Antoniuk P, Koness RJ, Levy A, Vezeridis M, Cohen SI, Wrobleski DE. Pelvic resection of recurrent rectal cancer: technical considerations and outcomes. Dis Colon Rectum. 1999;42(11):1438–48. doi: 10.1007/BF02235044.
    1. Moore HG, Shoup M, Riedel E, Minsky BD, Alektiar KM, Ercolani M, Paty PB, Wong WD, Guillem JG. Colorectal cancer pelvic recurrences: determinants of resectability. Dis Colon Rectum. 2004;47(10):1599–606. doi: 10.1007/s10350-004-0677-x.
    1. Georgiou PA, Tekkis PP, Brown G. Pelvic colorectal recurrence: crucial role of radiologists in oncologic and surgical treatment options. Cancer Imaging. 2011;11. Spec No A:S103–11. doi: 10.1102/1470-7330.2011.9025.
    1. Harji DP, Giffiths B, Mc Arthur DR, Sagar PM. Current UK management of locally recurrent rectal cancer. Colorectal Dis. 2012;14(12):1479–82. doi: 10.1111/j.1463-1318.2012.03070.x.
    1. Brazier JE, Harper R, Jones NM, O’Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305(6846):160–4. doi: 10.1136/bmj.305.6846.160.
    1. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8(3):181–95. doi: 10.1023/A:1008821826499.
    1. Donovan KA, Grassi L, McGinty HL, Jacobsen PB. Validation of the distress thermometer worldwide: state of the science. Psychooncology. 2014;23(3):241–50. doi: 10.1002/pon.3430.
    1. Mucchielli R. L’observation psychologique et psychosociologique. ESF Editeur: Paris; 1991.
    1. Norimatsu M, Pigem N. Les techniques d’observation en sciences humaines. Paris: Armand Collin; 2008.
    1. Barbin L. L’analyse de contenu. PUF: Paris; 1997.
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13. doi: 10.1097/.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅