A systematic review of heterogeneity in clinical trial design for anal cancer radiotherapy-immunotherapy combinations

Authors: Robert J. Samuel, Adel Samson, Duncan C. Gilbert, Richard Adams, Andrew Renehan, Natalie Cook, David Sebag-Montefiore, Sarah Brown

Source: Clinical and Translational Radiation Oncology, Vol 61, Iss , Pp 101243- (2026)

Subject Terms: Anal Cancer, Radiotherapy, Clinical Trials, Immunotherapy, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2405630826001382; https://doaj.org/toc/2405-6308

Access URL: https://doaj.org/article/9f3facd271754585a97eb866b367f802

Standard versus reduced-dose chemoradiotherapy in anal cancer (PLATO-ACT4): short-term results of a phase 2 randomised controlled trial

Authors: Alexandra Gilbert, Richard Adams, Joanne Webster, Duncan C Gilbert, Natalie L Abbott, Lindy Berkman, Daniel Bottomley, Sarah R Brown, Natalie Casanova, Joanne Copeland, Stephen Falk, Rob Glynne-Jones, Vicky Goh, Maria A Hawkins, Shaharyar Khan, Rebecca Muirhead, Sheela Rao, Andrew G Renehan, Susan D Richman, Sharon Ruddock, Alexandra Smith, Alexandra J Stewart, Max Whibley, Henry M Wood, David Sebag-Montefiore, Mark Harrison, Mark Saunders, Vicky McFarlane, Paul Shaw, Susan Cleator, Timothy Simmons, Asad Qureshi, Catherine Jephcott, Tom Richards, Deborah Williamson, Amandeep Dhadda, Hemal Ariyarantne, Melanie Osborne, Alice Dewdney, Peter Correa, Tareq Abdullah, Leslie Samuel, Rachel Lewis, Catriona McLean, Nick Reed, Karen Whitmarsh, Ian Geh, David Wilson

Source: The Lancet Oncology. 26:707-718

Subject Terms: Male, Adult, Mitomycin, Radiotherapy Dosage, Chemoradiotherapy, Middle Aged, Anus Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Humans, Female, Radiotherapy, Intensity-Modulated, Prospective Studies, Dose Fractionation, Radiation, Capecitabine, Aged, Neoplasm Staging

Access URL: https://pubmed.ncbi.nlm.nih.gov/40334666

1489 STAR-TREC (NCT02945566): A randomised phase II/III trial of CRT versus 5x5 Gy SCRT for organ preservation in early/intermediate risk rectal cancer

Authors: Corrie A.M. Marijnen, David Sebag-Montefiore, Victoria Homer, Simon Gates, Issam Al-Najami, Eva Angenete, Ane Appelt, Gunnar Baatrup, Geerard Beets, Jacobus W.A. Burger, Karen-Lise Garm Spindler, Ian Geh, Alexandra Gilbert, Karin Haustermans, Fabian Holman, Stephan Korsgen, Pehr Lind, Anna Martling, Femke Peters, Mark Teo, Nicholas West, Albert Wolthuis, Johannes W.H. de Wilt

Source: Radiotherapy and Oncology. 206:S1170-S1173

An international multi-centre study to develop and validate federated learning-based prognostic models for anal cancer

Authors: Stelios Theophanous, Per-Ivar Lønne, Ananya Choudhury, Maaike Berbee, Charlotte Deijen, Andre Dekker, Matthew Field, Maria Antonietta Gambacorta, Alexandra Gilbert, Marianne Grønlie Guren, Rashmi Jadon, Rohit Kochhar, Daniel Martin, Ahmed Allam Mohamed, Rebecca Muirhead, Oriol Parés, Łukasz Raszewski, Rajarshi Roy, Andrew Scarsbrook, David Sebag-Montefiore, Emiliano Spezi, Vassilios Vassiliou, Eirik Malinen, Leonard Wee, Ane Appelt, Richard Adams, Krystyna Adamska, Muhammad Amin, Nikola Dino Capocchiano, Philip Chlap, Peter Colley, Andrea Damiani, Viola De Luca, Antri Demetriou, Shrikant Deshpande, Michael J. Eble, Anthony Espinoza, Emmanouil Fokas, Loukia Georgiou, Ann Henry, Andrew Hoole, Lois C. Holloway, Thomas Jansen, Tomas Janssen, Alexandros Kritikopoulos, Joanna Y. G. Lau, Mark T. Lee, John Lilley, Gisela Lima, Patricia Lopes, Adam Loveday, Stefania Manfrida, Jenny Marsden, Carlotta Masciocchi, Joseph Mercer, Elisavet Papageorgiou, Gareth Price, Thomas Rackley, Claus Michael Rödel, Mariachiara Savino, Athina Sdrolia, Joep Stroom, Ioannis Stylianou, David Thwaites, Maciej Trojanowski, Vincenzo Valentini, Rens van Haveren, Baukelien van Triest, Amy Walker

Source: Nature Communications. 17

2186 ARISTOTLE: Mature results of a phase 3 trial evaluating the addition of irinotecan to capecitabine chemoradiation in locally advanced rectal cancer

Authors: David Sebag-Montefiore, Leslie Samuel, Simon Gollins, Robert Glynne-Jones, Robert Harte, Nicholas West, Philip Quirke, Arthur Sun Myint, Simon Bach, Stephen Falk, Philip Parsons, Amandeep Dhadda, Vivek Misra, Gina Brown, Mark Harrison, Laura White, Marian Duggan, Rubina Begum, Elizabeth Chang, Rukan Musleh, Andre Lopes, Richard Adams

Source: Radiotherapy and Oncology. 206:S1192-S1194

3895 Long term toxicity results of ACT4 RCT: evaluating reduced dose and standard dose chemoradiotherapy in early-stage anal cancer (ISRCTN:88455282)

Authors: Alexandra Gilbert, Joanne Webster, Sarah Brown, Joanne Copeland, Sharon Ruddock, Duncan Gilbert, Maria Hawkins, Rebecca Muirhead, Andrew Renehan, Natalie Abbott, Lindy Berkman, Chloe Gaul, Rob Glynne-Jones, Vicky Goh, Sheela Rao, Susan Richman, Alexandra Smith, Richard Adams, Mark Harrison, David Sebag Montefiore

Source: Radiotherapy and Oncology. 206:S1263-S1265

1913 Tumour-to-stroma ratio identified by artificial intelligence impacts cancer outcomes in a phase III randomised rectal chemo-radiotherapy trial

Authors: Zhuoyan Shen, Douglas Brand, Mikael Simard, Andre Lopes, Rubina Begum, Nicholas West, Ying Zhang, Sumeet Hindocha, Gary Royle, Tim Maughan, David Sebag-Montefiore, Charles Antoine Collins Fekete, Maria Hawkins

Source: Radiotherapy and Oncology. 206:S3759-S3761

3809 Cure vs. toxicity: quantifying preferences for non-surgical management of rectal cancer using a prospective discrete choice experiment study

Authors: Edward Jd Webb, Maureen Twiddy, Samantha Noutch, Ravi Adapala, Simon P. Bach, Sarah Brown, Carole Burnett, Alwyn Burrage, Alexandra Gilbert, Maria Hawkins, Debra Howard, Eleanor Hudson, Monica Jefford, Rohit Kochhar, Mark Saunders, Jenny Seligmann, Alexandra Smith, Mark Teo, Nicholas West, David Sebag Montefiore, Simon Gollins, Ane L. Appelt

Source: Radiotherapy and Oncology. 206:S1253-S1255

3665 PLATO ACT 4: Long term results of an RCT evaluating reduced dose and standard dose chemoradiotherapy in early-stage anal cancer (ISRCTN:88455282)

Authors: David Sebag-Montefiore, Mark Harrison, Alexandra Gilbert, Natalie Abbott, Lindy Berkman, Joanne Copeland, Duncan Gilbert, Chloe Gaul, Rob Glynne-Jones, Vicky Goh, Maria Hawkins, Rebecca Muirhead, Sheela Rao, Andrew Renehan, Susan Richman, Sharon Ruddock, Alexandra Smith, Joanne Webster, Sarah Brown, Richard Adams

Source: Radiotherapy and Oncology. 206:S1246-S1248

Pre-treatment magnetic resonance imaging in anal cancer: large-scale evaluation of mrT, mrN and novel staging parameters: large-scale evaluation of mrT, mrN and novel staging parameters

Authors: Hema Sekhar, Rohit Kochhar, Bernadette Carrington, Thomas Kaye, Damian Tolan, Lee Malcomson, Mark P. Saunders, Matthew Sperrin, David Sebag-Montefiore, Marcel van Herk, Andrew G. Renehan

Source: Br J Cancer
Sekhar, H, Kochhar, R, Carrington, B, Kaye, T, Tolan, D, Malcomson, L, Saunders, M P, Sperrin, M, Sebag-Montefiore, D, van Herk, M & Renehan, A G 2024, 'Pre-treatment magnetic resonance imaging in anal cancer : large-scale evaluation of mrT, mrN and novel staging parameters', British Journal of Cancer, vol. 131, no. 7, pp. 1137-1146. https://doi.org/10.1038/s41416-024-02759-8

Subject Terms: Male, Adult, Aged, 80 and over, Carcinoma, Chemoradiotherapy, Middle Aged, Anus Neoplasms/therapy, Squamous Cell/diagnostic imaging, Anus Neoplasms, Prognosis, Magnetic Resonance Imaging, Article, Magnetic Resonance Imaging/methods, Carcinoma, Squamous Cell/diagnostic imaging, 03 medical and health sciences, 0302 clinical medicine, 80 and over, Carcinoma, Squamous Cell, Humans, Female, Aged, Neoplasm Staging

Access URL: https://pubmed.ncbi.nlm.nih.gov/39169173
https://pure.amsterdamumc.nl/en/publications/16380377-325e-4861-acf9-1203529f45c7
https://doi.org/10.1038/s41416-024-02759-8

Personalising anal cancer radiotherapy dose (PLATO): protocol for a multicentre integrated platform trial

Authors: Mark Harrison, Vicky Goh, Lindy Berkman, Sarah Brown, Alexandra Smith, Sheela Rao, Susan D Richman, Andrew G Renehan, David Sebag-Montefiore, Natalie L Abbott, Richard Adams, Sharon P Ruddock, Alexandra Gilbert, Maria Hawkins, Rebecca Muirhead, Joanne Webster, Russell Frood, Duncan Gilbert, Joanne Copeland

Source: BMJ Open, Vol 15, Iss 11 (2025)

Subject Terms: Medicine

File Description: electronic resource

Relation: https://bmjopen.bmj.com/content/15/11/e109655.full; https://doaj.org/toc/2044-6055

Access URL: https://doaj.org/article/4b97cb6ac06e4562a7a3d183c91cab74

1317: Identifying Lymphocyte Infiltration for Rectal Cancer Outcome Prediction Using Phase III Trial Data

Authors: Zhuoyan Shen, Mikael Simard, Douglas Brand, Ying Zhang, Gary Royle, Andre Lopes, Rubina Begum, Nicholas West, Ane Appelt, Alexandra Gilbert, Tim Maughan, David Sebag-Montefiore, Maria A. Hawkins, Charles-Antoine Collins Fekete

Source: Radiotherapy and Oncology. 194:S4466-S4470

1294: A Multi-Omics Database Using Clinical Trial Data for Rectal Cancer Radiotherapy Outcome Prediction

Authors: Zhuoyan Shen, Douglas Brand, Mikael Simard, Ying Zhang, Gary Royle, Andre Lopes, Rubina Begum, Nicholas West, Ane Appelt, Alexandra Gilbert, Elizabeth Miles, Tim Maughan, David Sebag-Montefiore, Charles-Antoine Collins-Fekete, Maria A. Hawkins

Source: Radiotherapy and Oncology. 194:S4463-S4466

Early outcomes of the PLATO ACT5 randomised trial: Personalizing anal cancer radiotherapy dose

Authors: Maria A. Hawkins, Alexandra Gilbert, Richard Adams, Lindy Berkman, Joanne Copeland, Duncan C. Gilbert, Mark Harrison, Robert Glynne-Jones, Vicky Goh, Chloe Gaul, Andrew Renehan, Rebecca Muirhead, Matthew Norris, Sheela Rao, Susan D. Richman, Sharon Ruddock, Joanne Webster, Sarah R. Brown, David Sebag-Montefiore

Source: Journal of Clinical Oncology. 44:1-1

Standard Versus Dose Reduced Chemoradiotherapy in Anal Cancer: Short Term Results of the PhaseII PLATO-ACT4 Randomised Controlled Trial (RCT) ISRCTN88455282

Authors: Alexandra Gilbert, Richard A. Adams, Webster Joanne, Duncan C. Gilbert, Natalie Abbott, Lindy Berkman, Daniel Bottomley, Sarah Brown, Nathalie Casanova, Joanne Copeland, Stephen Falk, Robert Glynne-Jones, Vicky Goh, Maria Hawkins, Shaharyar Khan, Rebecca Muirhead, Sheela Rao, Andrew Renehan, Susan Richman, Sharon Ruddock, Alexandra Smith, Alexandra J. Stewart, Max Whibley, Henry Wood, David Sebag-Montefiore, Mark Harrison

Interpretable Prediction of Lymphopenia Following Neo-Adjuvant Chemo-Radiotherapy for Rectal Cancer: An Analysis of the ARISTOTLE Randomised Phase III Trial

Authors: Ying Zhang, Douglas Brand, Sumeet Hindocha, Ane Appelt, Nick P. West, Zhuoyan Shen, Andre Lopes, Rubina Begum, Alexandra Gilbert, Elizabeth Miles, Tim Maughan, David Sebag-Montefiore, Charles-Antoine Collins Fekete, Maria Hawkins

AI-powered immune profiling from histopathology slides for chemo-radiotherapy outcome prediction in rectal cancer: a study using clinical trial and real-world cohorts

Authors: Zhuoyan Shen, Douglas Brand, Mikaël Simard, Adam P. Levine, Sumeet Hindocha, Talisa Mistry, Dahmane Oukrif, Andre Lopes, Rubina Begum, Nicholas P. West, Ying Zhang, Gary Royle, Tim S. Maughan, David Sebag-Montefiore, Maria A. Hawkins, Charles-Antoine Collins-Fekete

Source: eBioMedicine

Subject Terms: Male, Adult, Rectal Neoplasms, Macrophages, Articles, Chemoradiotherapy, Middle Aged, Prognosis, Neoadjuvant Therapy, Lymphocytes, Tumor-Infiltrating, Treatment Outcome, Mutation, Tumor Microenvironment, Biomarkers, Tumor, Humans, Female, Aged

Access URL: https://pubmed.ncbi.nlm.nih.gov/41253645
https://pubmed.ncbi.nlm.nih.gov/41253645/
https://pmc.ncbi.nlm.nih.gov/articles/PMC12790592/
https://doi.org/10.1016/j.ebiom.2025.105993

Image-based consensus molecular subtyping in rectal cancer biopsies and response to neoadjuvant chemoradiotherapy

Authors: Maxime W. Lafarge, Enric Domingo, Korsuk Sirinukunwattana, Ruby Wood, Leslie Samuel, Graeme Murray, Susan D. Richman, Andrew Blake, David Sebag-Montefiore, Simon Gollins, Eckhard Klieser, Daniel Neureiter, Florian Huemer, Richard Greil, Philip Dunne, Philip Quirke, Lukas Weiss, Jens Rittscher, Tim Maughan, Viktor H. Koelzer

Source: npj Precision Oncology, Vol 8, Iss 1, Pp 1-11 (2024)

Subject Terms: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282

File Description: electronic resource

Relation: https://doaj.org/toc/2397-768X

Access URL: https://doaj.org/article/069ba3e2373e479787af9c5a62731f11

Quality-of-life outcomes in older patients with early-stage rectal cancer receiving organ-preserving treatment with hypofractionated short-course radiotherapy followed by transanal endoscopic microsurgery (TREC): non-randomised registry of patients unsuitable for total mesorectal excision

Authors: Alexandra Gilbert, Victoria Homer, Kristian Brock, Stephan Korsgen, Ian Geh, James Hill, Talvinder Gill, Paul Hainsworth, Matthew Tutton, Jim Khan, Jonathan Robinson, Mark Steward, Christopher Cunningham, Manjinder Kaur, Laura Magill, Ann Russell, Philip Quirke, Nicholas P West, David Sebag-Montefiore, Simon P Bach, Alan Beveridge, Bruce Levy, Kelly Handley, Gina Brown, Peter Antonio, Alex Vince, Nick Hilken, Chakanaka Sidile, Adrian Wilcockson, Richard Peto, Tom Crosby, Brendan Moran, Julie Olliff, Katti Ashok, Simone Slawik, Andrew Smethurst, Rajaram Sripadam, Veena Tagore, Monica Terlizzo, Bearn Philip, Robert Davies, Susan Dodd, Sharadah Essapen, Pasha Nisar, Alexandra Stewart, Jonathan Trickett, Bansal Ashish, Peter Billings, Palanichamy Chandran, Conor Corr, Edward Favill, Simon Gollins, Peter Marsh, Andrew Maw, Rakha Neupane, Ramesh Rajagopal, Rachel Cooper, John Griffith, Paul Hatfield, Andy Lowe, Julian Ostrowski, Rhian Simpson, Richard Adams, Robert Bleehen, Michael Davies, Meleri Morgan, Darren Boone, Nicola Lacey, Ian Seddon, Bruce Sizer, Helen Stunell, Shaobin Wu, Maher Hadaki, Dominic Blunt, Susan Cleator, Ara Darzi, Robert Goldin, Paul Ziprin, Mike Dobson, Mark Pitt, Shabbir Susnerwala, Deborah Williamson, Georgina Howarth, Stephen Lee, Paul Wright, Tim Hoare, Alan Horgan, Fiona McDonald, Stephanie Needham, John Scott, Timothy Simmons, Debashis Biswas, James Hernon, Gaurav Kapur, Sandeep Kapur, James Sington, Christopher Speakman, William Stebbings, Stuart Williams, Madhavi Adusumalli, Anil Agarwal, David Borowski, Dharmendra Garg, Mohammed Hegab, Catherine Hobday, Veena Rao, Jyotsna Shrimankar, Mohamed Tabaqchali, David Wilson, Oliver Jones, Neil Mortensen, Andrew Slater, Aron Szuts, Lai Wang, Bryan Warren, Andrew Weaver, Mukhtar Ahmad, Julian Alexander, Maxine Flubacher, David Tarver, Suhail Baluch, Richard Beable, David Cowlishaw, Antony Higginson, Prokopios Vogiatzis, Neil Cruickshank, Howard Joy, David Peake, Ulises Zanetto, Mark Saunders, Arthur Sun-Myint, Mark Teo, Arthur Allan, John Glaholm, Mark Goldstein, Rahul Hejmadi, Gerald Langman, Dion Morton, Cyril Nelson, Deborah Tattersall, Stephen Falk, Robert Longman, Huw Roach, Jamshed Shabbir, Golda Shelley-Fraser, Michael Thomas, Neil Cripps, Yasser Haba, Guy Harris, Max Hookway, Jay Simson, Angela Skull, Tijani Umar

Source: Lancet Healthy Longev

Subject Terms: 03 medical and health sciences, 0302 clinical medicine, Rectal Neoplasms, Quality of Life, Humans, Articles, Colorectal Neoplasms, Aged, 3. Good health

File Description: application/pdf

Access URL: https://pubmed.ncbi.nlm.nih.gov/36403589

International consensus to define outcomes for trials of chemoradiotherapy for anal cancer (CORMAC-2): defining the outcomes from the CORMAC core outcome set

Authors: Robert Samuel, Stephen R. Knight, Richard Adams, Prajnan Das, Jennifer Dorth, David Finch, Marianne G. Guren, Maria A. Hawkins, Susan Moug, Lakshmi Rajdev, David Sebag-Montefiore, Andrew G. Renehan, Rebecca Fish, Miguel A. Rodriguez-Bigas, Pratik Adusumilli, Ahmed Allam Mohamed, Mario Alvarez Gallego, Eva Angenete, Ane Appelt, Maaike Berbee, Danielle Brogden, Peter Brown, Lucy Buckley, Nathalie Casanova, Rachel Cooper, Nuno Couto, Peter Coyne, Tamzin Cuming, Charlotte Deijin, Kristopher Dennis, Cathy Eng, Alexandra Gilbert, Duncan Gilbert, Karyn Goodman, Rashmi Jadon, Anders Johnsson, Arunansu Kar, Ethan Ludmir, Marie-Louise Lydrup, Ivan Lyra-Gonzalez, Stefania Manfrida, Rebecca Muirhead, Sarah O'Dwyer, Thomas Rackley, Lukasz Raszewski, Leslie Samuel, Mark Saunders, Andrew Scarsbrook, Eva Segelov, Timothy Simmons, Paul Sutton, Nicholas Symons, Deborah Williamson

Source: EClinicalMedicine, Vol 78, Iss , Pp 102939- (2024)

Subject Terms: Core outcome set, Outcomes, Anal cancer, Consensus, Delphi, Chemoradiotherapy, Medicine (General), R5-920

File Description: electronic resource

Relation: http://www.sciencedirect.com/science/article/pii/S2589537024005182; https://doaj.org/toc/2589-5370

Access URL: https://doaj.org/article/13141decd4db43eeae1e82431775d0e8