The ARISTOTLE study is reported as a multicentre, open-label, phase 3 randomized controlled trial evaluating the addition of irinotecan to standard preoperative chemoradiotherapy for patients with locally advanced rectal cancer. The trial title and descriptors indicate the intervention was given in the preoperative setting with the objective of assessing irinotecan when combined with chemoradiotherapy before surgery.
The published citation in Lancet Oncology is: Sebag-Montefiore D et al., Addition of irinotecan to chemoradiotherapy as preoperative treatment for locally advanced rectal cancer (ARISTOTLE): a multicentre, open-label, phase 3, randomized controlled trial. Lancet Oncol. 2026 Aug;27(8):1004–1019. PubMed PMID: 42508427. DOI: 10.1016/S1470-2045(26)00132-4.
The study is described in source material as multicentre and open-label. "Multicentre" indicates enrollment across multiple clinical sites; the author and collaborator listings show participation from a wide range of UK cancer centres and academic units. "Open-label" denotes that investigators and participants were aware of treatment allocation rather than blinded.
The source identifies ARISTOTLE as a phase 3 randomized controlled trial, implying a confirmatory efficacy and safety comparison against a control or standard regimen. No further methodological details (for example, randomization ratio, stratification factors, sample size, or follow-up duration) are provided in the supplied excerpt.
Per the title and trial name, the experimental strategy was the addition of irinotecan to preoperative chemoradiotherapy for locally advanced rectal cancer. The source does not report specifics such as chemotherapy backbones used (fluoropyrimidine type or schedule), irinotecan dosing, radiation dose and fractionation, timing of surgery, or supportive-care protocols. Those detailed regimen elements are not present in the provided content.
The paper lists David Sebag-Montefiore as first author and names many co-authors and collaborators. Institutional affiliations cited in the source include (but are not limited to): Leeds Institute of Medical Research (University of Leeds), Centre for Trials Research (Cardiff University), North Wales Cancer Treatment Centre, Aberdeen Royal Infirmary, Mount Vernon Cancer Centre, Belfast City Hospital Northern Ireland Cancer Centre, Clatterbridge Cancer Centre NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, Velindre University NHS Trust, Castle Hill Hospital, Calderdale and Huddersfield NHS Foundation Trust, Department of Surgery and Cancer (Imperial College London), Radiotherapy Physics Department (Velindre), and Cancer Research UK and UCL Cancer Trials Centre.
An extensive ARISTOTLE Trial Management Group and Investigators list is provided in the source, confirming broad multidisciplinary and multi-institutional involvement across UK centres. The names and affiliations in the source establish the trial as a large collaborative effort, but no site-level enrollment numbers or recruitment periods are reported here.
The supplied content includes standard bibliographic indexing: journal (Lancet Oncology), publication date and volume/issue (2026 Aug;27[8]:1004–1019), DOI (10.1016/S1470-2045(26)00132-4), and PubMed identifier (PMID 42508427). The format shown classifies the article as a Clinical Trial.
The excerpted PubMed page and clipped source text present title, author list, collaborators, affiliations, citation, DOI, and PMID. However, the supplied material does not include the abstract text, trial results, numerical efficacy outcomes, toxicity data, statistical analyses, or authors' interpretation.
Specifically, the following essential trial details are missing from this excerpt and therefore cannot be described here: eligibility criteria, enrollment numbers, randomization scheme, primary and secondary endpoints, event rates or effect sizes, measures of statistical significance, adverse-event frequencies and grades, pathologic response or surgical outcomes, follow-up duration, and subgroup analyses.
Because these data are not present in the provided content, no conclusions about the efficacy or safety of adding irinotecan to preoperative chemoradiotherapy in locally advanced rectal cancer can be drawn from this excerpt alone. To evaluate outcomes, harm-benefit balance, or potential practice implications, readers should consult the full published article in Lancet Oncology or the complete PubMed abstract and supplementary materials.
This source confirms that a multicentre phase 3 randomized trial (ARISTOTLE) investigating irinotecan in the preoperative chemoradiotherapy setting for locally advanced rectal cancer has been completed and reported in a high-impact oncology journal. For clinicians, guideline authors, and investigators seeking to interpret the trial or consider its impact on practice, the necessary next step is to review the full paper to obtain trial methods, statistical results, safety data, and authors' conclusions. The PubMed record (PMID 42508427) and the DOI provide direct routes to the full text and associated materials.
Note: All content in this summary is limited to information present in the supplied PubMed excerpt. Details such as numerical results, specific regimen elements, and outcome data were not reported in the source material provided here.