{"id":2307,"date":"2026-05-12T09:57:09","date_gmt":"2026-05-12T07:57:09","guid":{"rendered":"https:\/\/www.clerad.fr\/opera-5-years-results\/"},"modified":"2026-05-13T15:24:42","modified_gmt":"2026-05-13T13:24:42","slug":"opera-5-years-results","status":"publish","type":"post","link":"https:\/\/www.clerad.fr\/en\/opera-5-years-results\/","title":{"rendered":"OPERA &#8211; 5 years results"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Background<\/h2>\n\n<p>The OPERA trial has shown that a <strong>contact X-ray brachytherapy 50 kV<\/strong> (CXB) boost with <strong>neoadjuvant<br\/>chemoradiotherapy (NCRT)<\/strong> can increase <strong>organ preservation (OP)<\/strong> rate for <strong>early rectal adenocarcinoma (ADK)<\/strong> of lowmid rectum. We report the results after <strong>5 years of follow-up<\/strong>.<\/p>\n\n<h2 class=\"wp-block-heading\">Patients and methods:<\/h2>\n\n<p>OPERA was a multicentre, phase III trial that included operable patients (pts), with cT2-cT3b low-mid rectal ADK, tumours &lt;5 cm, cN0 or cN1 &lt;8 mm.<\/p>\n\n<p>All pts received external beam radiotherapy (EBRT): 45 Gy in 25 fractions with concurrent capecitabine.<\/p>\n\n<p>Pts were randomly assigned (1:1) to receive :<\/p>\n\n<ul class=\"wp-block-list\">\n<li>a boost of EBRT in group A (9 Gy\/5 fractions)<\/li>\n\n\n\n<li>a boost with CXB (90 Gy\/3 fractions) in group B.<\/li>\n<\/ul>\n\n<p>The primary end point was OP rate.<\/p>\n\n<h2 class=\"wp-block-heading\">Results:<\/h2>\n\n<p>Out of 148 patients randomised, 141 were eligible.<\/p>\n\n<p>Between week 14-24, a clinical complete (or near) response was observed in 44 pts in group A (64%) versus 66 in group B (92%); P &lt; 0.001. T<\/p>\n\n<p>The 3-year OP rate was 59% in group A versus 81% in group B (P \u00bc 0.003).<\/p>\n\n<p>After update the median follow-up was 61.1 months [56.8-64.5]. The 5-year local regrowth was 39% in group A and 17% in group B (P \u00bc 0.1).<\/p>\n\n<p>The difference in OP was still highly significant between both groups: A 56% versus B 79% (P \u00bc 0.004).<\/p>\n\n<p>The difference was more significant if tumours &lt;3 cm, with an OP rate of 93% in group B compared to 54% in group A.<\/p>\n\n<p>Of the 28 local regrowths, 3 occurred after 3 years of follow-up. Rectal bleeding (grade 1-2), which was the most prevalent toxicity during follow-up, disappeared most of the time after three years. Bowel function was not worsened by the CXB boost.<\/p>\n\n<h2 class=\"wp-block-heading\">Conclusion<\/h2>\n\n<p>The OPERA trial was the first trial to demonstrate that CXB dose escalation was increasing the OP rate with good bowel function at 3 years.<\/p>\n\n<p>At 5 years, these results are sustained, especially in small early-stage tumours. The occurrence of some local regrowth after 3 years necessitates close surveillance of these pts during the 5-year period.<\/p>\n\n<div data-wp-interactive=\"core\/file\" class=\"wp-block-file\"><object data-wp-bind--hidden=\"!state.hasPdfPreview\" hidden class=\"wp-block-file__embed\" data=\"http:\/\/www.clerad.fr\/wp-content\/uploads\/2026\/05\/OPERA-5-years-results.pdf\" type=\"application\/pdf\" style=\"width:100%;height:600px\" aria-label=\"Embed of OPERA 5 years results.\"><\/object><a id=\"wp-block-file--media-86408c07-3c9b-4877-8dbd-a63289940c40\" href=\"http:\/\/www.clerad.fr\/wp-content\/uploads\/2026\/05\/OPERA-5-years-results.pdf\">OPERA 5 years results<\/a><a href=\"http:\/\/www.clerad.fr\/wp-content\/uploads\/2026\/05\/OPERA-5-years-results.pdf\" class=\"wp-block-file__button wp-element-button\" download=\"\" aria-describedby=\"wp-block-file--media-86408c07-3c9b-4877-8dbd-a63289940c40\">Download<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The OPERA trial has shown that a contact X-ray brachytherapy 50 kV (CXB) boost with neoadjuvant<br \/>chemoradiotherapy (NCRT) can increase organ preservation (OP) rate for early rectal adenocarcinoma (ADK) of lowmid rectum. <\/p>\n","protected":false},"author":1,"featured_media":2306,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15],"tags":[],"class_list":["post-2307","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-resources"],"_links":{"self":[{"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/posts\/2307","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/comments?post=2307"}],"version-history":[{"count":1,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/posts\/2307\/revisions"}],"predecessor-version":[{"id":2309,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/posts\/2307\/revisions\/2309"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/media\/2306"}],"wp:attachment":[{"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/media?parent=2307"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/categories?post=2307"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.clerad.fr\/en\/wp-json\/wp\/v2\/tags?post=2307"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}