Artikel
Trial protocol of LION – Lymphadenectomy in Ovarian Neoplasm (AGO-OVAR OP.3)
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Autoren
Veröffentlicht: | 10. September 2008 |
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Gliederung
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Clinical Background
Pelvic and para-aortic lymphadenectomy (LNE) is well established as part of comprehensive surgical staging in early stage ovarian cancer whereas its role in advanced ovarian cancer (AOC) is unclear. Retrospective analyses indicate a potential benefit of LNE in patients with macroscopically complete intraabdominal resection. However, prospective randomized trials are lacking and a randomized trial in a mixed population composed of both completely debulked patients (30%) and those with small residual tumor intraabdominally (70%) could only show a significant impact of LNE on progression-free survival but not on survival [Ref. 1]. The lack of sound evidence in this area is reflected by the heterogeneous LNE usage in Germany.
Methods
LION – Lymphadenectomy in Ovarian Neoplasm, a prospectively randomized controlled multicentre phase III trial, planned by Arbeitsgemeinschaft Gynäkologische Onkologie Studiengruppe and funded by Deutsche Forschungsgemeinschaft (DFG) will clarify the role of LNE in AOC. Endpoints include overall and progression-free survival but also quality of life and tolerability, thus allowing to balance supposed objective improvement with subjective outcome results. Different sources of bias exist in this setting, e.g. surgical skill or different subsequent chemotherapies. Additionally, participation in a surgical trial may impact the results of a subsequent chemotherapy study. To minimize bias through surgical skills a training program and qualification of the participating surgeons is necessary. Bias through subsequent chemotherapy will be accounted for by balancing subsequent chemotherapy trials for LION intervention resp. participation and using chemotherapy as a covariate in the final analysis. We summarize the methodological and statistical measures stated in the trial protocol.
Conclusions
The evaluation of a surgical add-on procedure as part of multimodal treatment in oncology presents various methodological challenges, which should be taken into account at the planning stage of a clinical trial.
References
- 1.
- Benedetti Panici P, Maggioni A, Hacker N, et al. Systematic aortic and pelvic lymphadenectomy versus resection of bulky nodes only in optimally debulked advanced ovarian cancer: a randomized clinical trial. J Natl Cancer Inst. 2005;97:560-6.