{"entity":{"id":"opra","kind":"trial","name":"OPRA","aka":[],"tldr":"OPRA showed that about half of people with rectal cancer who receive all their chemotherapy and radiotherapy before surgery can keep their rectum without any drop in the chance of cure, and that giving the chemotherapy after the radiotherapy preserves more rectums.","summary":"OPRA randomised 324 patients with MRI-staged stage II or III rectal cancer to induction FOLFOX or CAPOX followed by chemoradiation, or to chemoradiation followed by consolidation FOLFOX or CAPOX. Patients with a clinical complete or near-complete response were offered watch and wait rather than total mesorectal excision.\n\nThree-year disease-free survival was 76 percent in both arms, no different from the historical rate with chemoradiation and surgery. Three-year survival without total mesorectal excision was 41 percent with induction chemotherapy and 53 percent with consolidation chemotherapy; regrowth after watch and wait was salvaged by surgery in almost every case without loss of disease control.\n\nOPRA made organ preservation a planned outcome of rectal cancer treatment rather than a chance finding, and the consolidation sequence is now the preferred order when the goal is to avoid surgery.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02008656","url":"https://clinicaltrials.gov/study/NCT02008656"},{"label":"Journal of Clinical Oncology 2022","url":"https://doi.org/10.1200/JCO.22.00032"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt","mri"],"targets":[],"drugs":["folfox","capox"],"companies":[],"institutions":["mskcc"],"pathways":[],"terms":["total-neoadjuvant-therapy","organ-preservation","clinical-complete-response","total-mesorectal-excision","chemoradiation"],"trials":[],"people":["julio-garcia-aguilar"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02008656","phase":"2","setting":"Stage II or III rectal adenocarcinoma: total neoadjuvant therapy as induction chemotherapy then chemoradiation, or chemoradiation then consolidation chemotherapy, with watch and wait offered to patients whose tumour disappeared","sponsor":"Memorial Sloan Kettering Cancer Center","result":"3-year disease-free survival 76% in both arms; 3-year survival without total mesorectal excision 41% (induction) vs 53% (consolidation).","yearReported":2022,"enrolled":324,"outcomes":[{"endpoint":"Survival without total mesorectal excision at 3 years","primary":true,"unit":"%","arms":[{"name":"Induction chemotherapy then chemoradiation","n":158,"value":41},{"name":"Chemoradiation then consolidation chemotherapy","n":166,"value":53}],"source":"https://doi.org/10.1200/JCO.22.00032"},{"endpoint":"Disease-free survival at 3 years","unit":"%","arms":[{"name":"Induction chemotherapy then chemoradiation","n":158,"value":76},{"name":"Chemoradiation then consolidation chemotherapy","n":166,"value":76}],"source":"https://doi.org/10.1200/JCO.22.00032"}],"replication":"Consistent with the Habr-Gama single-centre series and the International Watch and Wait Database; RAPIDO and PRODIGE 23 confirm the disease-control side of total neoadjuvant therapy."},"route":"/trials/opra/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"},{"id":"mri","kind":"technology","name":"MRI","route":"/technologies/mri/"}],"drug":[{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"}],"institution":[{"id":"mskcc","kind":"institution","name":"Memorial Sloan Kettering Cancer Center","route":"/institutions/mskcc/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"},{"id":"clinical-complete-response","kind":"term","name":"Clinical complete response (cCR)","route":"/terms/clinical-complete-response/"},{"id":"organ-preservation","kind":"term","name":"Organ preservation (watch-and-wait, bladder-sparing, larynx preservation)","route":"/terms/organ-preservation/"},{"id":"total-mesorectal-excision","kind":"term","name":"Total mesorectal excision (TME)","route":"/terms/total-mesorectal-excision/"},{"id":"total-neoadjuvant-therapy","kind":"term","name":"Total neoadjuvant therapy (TNT, rectal cancer)","route":"/terms/total-neoadjuvant-therapy/"}],"person":[{"id":"julio-garcia-aguilar","kind":"person","name":"Julio Garcia-Aguilar","route":"/people/julio-garcia-aguilar/"}]}}