dc.contributor.author | Slater, S | |
dc.contributor.author | Bryant, A | |
dc.contributor.author | Chen, H-C | |
dc.contributor.author | Begum, R | |
dc.contributor.author | Rana, I | |
dc.contributor.author | Aresu, M | |
dc.contributor.author | Peckitt, C | |
dc.contributor.author | Zhitkov, O | |
dc.contributor.author | Lazaro-Alcausi, R | |
dc.contributor.author | Borja, V | |
dc.contributor.author | Powell, R | |
dc.contributor.author | Lowery, D | |
dc.contributor.author | Hubank, M | |
dc.contributor.author | Rich, T | |
dc.contributor.author | Anandappa, G | |
dc.contributor.author | Chau, I | |
dc.contributor.author | Starling, N | |
dc.contributor.author | Cunningham, D | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2023-06-07T09:46:39Z | |
dc.date.available | 2023-06-07T09:46:39Z | |
dc.date.issued | 2023-03-20 | |
dc.identifier | ARTN 257 | |
dc.identifier | 10.1186/s12885-023-10699-4 | |
dc.identifier.citation | BMC Cancer, 2023, 23 (1), pp. 257 - | |
dc.identifier.issn | 1471-2407 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5830 | |
dc.identifier.eissn | 1471-2407 | |
dc.identifier.eissn | 1471-2407 | |
dc.identifier.doi | 10.1186/s12885-023-10699-4 | |
dc.description.abstract | BACKGROUND: Circulating tumour DNA (ctDNA) to detect minimal residual disease (MRD) is emerging as a biomarker to predict recurrence in patients with curatively treated early stage colorectal cancer (CRC). ctDNA risk stratifies patients to guide adjuvant treatment decisions. We are conducting the UK's first multi-centre, prospective, randomised study to determine whether a de-escalation strategy using ctDNA to guide adjuvant chemotherapy (ACT) decisions is non-inferior to standard of care (SOC) chemotherapy, as measured by 3-year disease free survival (DFS) in patients with resected CRC with no evidence of MRD (ctDNA negative post-operatively). In doing so we may be able to spare patients unnecessary chemotherapy and associated toxicity and achieve significant cost savings for the National Health Service (NHS). METHODS: We are recruiting patients with fully resected high risk stage II and stage III CRC who are being considered for ACT into the study which uses results from a plasma-only ctDNA assay to guide treatment decisions. Eligible patients are randomised 1:1 to receive ctDNA-guided chemotherapy versus SOC chemotherapy. The primary endpoint is the difference in DFS at 3 years between the trial arms. Secondary endpoints include the proportion of patients in the ctDNA-guided arm who are ctDNA negative post-operatively and receive de-escalated ACT compared to the standard arm, the difference in overall survival (OS), neurotoxicity and quality of life between the arms, and the cost-effectiveness of ctDNA-guided therapy compared to SOC treatment. We hypothesise that using a ctDNA-guided approach to ACT decisions is non-inferior to SOC. Target accrual is 1621 patients over 4 years, which will provide a power of 80% with an alpha of 0.1 to demonstrate non-inferiority with a margin of 1.25 in survival of the ctDNA-guided approach compared to SOC. We anticipate approximately 50 UK centres will participate. The study opened with the Guardant Reveal plasma-only ctDNA assay in August 2022. DISCUSSION: The trial will determine whether ctDNA guided ACT is non-inferior to SOC ACT in patients with fully resected high risk stage II and stage III resected CRC, with the potential to significantly reduce unnecessary ACT and the toxicity associated with it. TRIAL REGISTRATION: NCT04050345. | |
dc.format | Electronic | |
dc.format.extent | 257 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | BMC | |
dc.relation.ispartof | BMC Cancer | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Adjuvant chemotherapy | |
dc.subject | Colorectal cancer | |
dc.subject | Disease free survival | |
dc.subject | Randomised | |
dc.subject | ctDNA | |
dc.subject | Humans | |
dc.subject | State Medicine | |
dc.subject | Quality of Life | |
dc.subject | Prospective Studies | |
dc.subject | Standard of Care | |
dc.subject | Colorectal Neoplasms | |
dc.subject | Chemotherapy, Adjuvant | |
dc.subject | Disease-Free Survival | |
dc.title | ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy after curative surgery in patients with high risk stage II or stage III colorectal cancer: a multi-centre, prospective, randomised control trial (TRACC Part C). | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-03-02 | |
dc.date.updated | 2023-06-07T09:45:48Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1186/s12885-023-10699-4 | |
rioxxterms.licenseref.startdate | 2023-03-20 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36941575 | |
pubs.issue | 1 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Gastrointestinal Cancers Clinical Trials | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Molecular Pathology | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Molecular Pathology/Translational Genomics | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Molecular Pathology/Translational Genomics/Translational Genomics (hon.) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1186/s12885-023-10699-4 | |
pubs.volume | 23 | |
icr.researchteam | GI Clinical Trials | |
dc.contributor.icrauthor | Slater, Susanna | |
dc.contributor.icrauthor | Anandappa, Gayathri | |
icr.provenance | Deposited by Mr Arek Surman on 2023-06-07. Deposit type is initial. No. of files: 1. Files: ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy after curative surgery in patients with hig.pdf | |