Journal of Clinical Oncology, Vol 22, No 12 (June 15), 2004: pp. 2404-2409
© 2004 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2004.08.170
Improved Sphincter Preservation in Low Rectal Cancer With High-Dose Preoperative Radiotherapy: The Lyon R96-02 Randomized Trial
Jean-Pierre Gerard,
Olivier Chapet,
Chantal Nemoz,
Johannes Hartweig,
Pascale Romestaing,
Regis Coquard,
Nicolas Barbet,
Philippe Maingon,
Marc Mahe,
Jacques Baulieux,
Christian Partensky,
Marc Papillon,
Olivier Glehen,
Bruno Crozet,
Jean-Paul Grandjean,
Patrice Adeleine
From the Department of Radiotherapy, Centre Antoine-Lacassagne, Nice; Department of Radiotherapy and Department of General Surgery CHU Lyon Sud, Pierre Bênite; Department of Biostatistics, Department of General Surgery, Hôpital Croix Rousse, Hôpital Edouard Herriot, CHU Lyon, and Clinique Charcot, Sainte Foy, Lyon; Clinique Saint-Jean, Lyon; Clinique Denis, MÂcon; Department of Radiotherapy, Centre George-François Leclerc, Dijon; Department of Radiotherapy, Centre René Gauducheau, Nantes; Clinique Trenel, Vienne; Clinique Sainte Marie-Thérèse, Bron, France
Address reprint requests to Jean-Pierre Gérard, MD, Centre Antoine-Lacassagne, 33 Avenue de Valombrose, 06189 Nice Cedex 2, France; e-mail: jean-pierre.gerard{at}cal.nice.fnclcc.fr
PURPOSE: The potential advantage of high-dose preoperative radiotherapy to increase tumor response and improve the chance of sphincter preservation for low rectal cancer remains controversial. The aim of this trial was to evaluate the role of escalating the dose of preoperative radiation to increase sphincter-saving procedures.
PATIENTS AND METHODS: Patients with rectal carcinoma located in the lower rectum, staged T2 or T3, Nx, or M0 with endorectal sonography, and not involving more than two-thirds circumference, were randomly assigned to one of two groups: preoperative external-beam radiotherapy (EBRT; 39 Gy in 13 fractions over 17 days) versus the same EBRT with boost (85 Gy in three fractions) using endocavitary contact x-ray.
RESULTS: Between 1996 and 2001, 88 patients were enrolled onto the study. A significant improvement was seen in favor of the contact x-ray boost for complete clinical response (24% v 2%) and for a complete or near-complete sterilization of the operative specimen (57% v 34%). A significant increase in sphincter preservation was observed in the boost group (76% v 44%; P = .004). At a median follow-up of 35 months, there was no difference in morbidity, local relapse, and 2-year overall survival.
CONCLUSION: A dose escalation with endocavitary irradiation provides increased tumor response and sphincter preservation with no detrimental effect on treatment toxicity and early clinical outcome.
Presented at the 45th Annual Meeting of the American Society of Therapeutic Radiology and Oncology, Salt Lake City, UT, October 21, 2003.
Authors' disclosures of potential conflicts of interest are found at the end of this article.

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