Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
NCT ID: NCT04050345
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2016-12-05
2031-07-31
Brief Summary
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TRACC Part C is a : (multi-centre, prospective, randomised study, of ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy study after curative surgery in patients with high risk stage II or stage III CRC. )It aims to demonstrate that a de-escalation strategy of ctDNA guided adjuvant chemotherapy is non- inferior to standard of care treatment as measured by 3 year disease free survival (DFS) in patients with high risk stage II or stage III colorectal cancer CRC with no evidence of minimal residual disease (MRD) (ctDNA negative)
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Detailed Description
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Circulating cell free tumour DNA (ctDNA) maintains the same mutations that are present in tumour. In colorectal cancer CRC, primary tumours and\& metastases exhibit high genomic concordance. Therefore the TRACC study TRACC Part B is investigating whether serial blood samples taken from in patients with stage II and III fully resected early stage CRC colorectal cancer that have undergone potentially curative surgery, blood samples to can be used to detect and\& quantify ctDNA may in order to identify minimal residual disease MRD and predict relapse earlier than existing methods. CtDNA may ultimately help identify a subset of patients that are or are unlikely to benefit from adjuvant chemotherapy and could therefore safely spare some patients from receiving unnecessary chemotherapy \& its associated side-effects.
TRACC Part C: We hypothesis that ctDNA guided adjuvant chemotherapy administration will enable biomarker driven selection of patients who would and would not benefit from adjuvant chemotherapy and thereby reduce the proportion of patient receiving unnecessary adjuvant chemotherapy, reducing the potential side effects associated with it, but without compromising disease free survival (DFS). : This part of the study will use tThe blood test ctDNA result from a post-operative blood sample willto guide adjuvant chemotherapy treatment decisions. The study aims to demonstrate that athe de -escalation strategy of ctDNA guided adjuvant chemotherapy is non-inferior to standard of care treatment as measured by 3 year DFS in patients with high risk stage II and stage III CRC, in those who have no evidence of MRD (ctDNA negative). after surgery for patients with colorectal cancer who are following the standard of care pathway. Patients are randomised at the post- operative time point to: Arm A (standard of care adjuvant chemotherapy), or Arm B (ctDNA guided adjuvant chemotherapy) arm. For the ct DNA guided arm, patients who are ctDNA negative at this time point will have their chemotherapy de-escalated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Part B TRACC Colon
Patients with diagnosis of large bowel cancer (in the colon) and no evidence of metastatic disease
No interventions assigned to this group
Part B TRACC Rectal
Patients who have a diagnosis of large bowel cancer (in the Rectum) and no evidence of metastatic disease
No interventions assigned to this group
Part C TRACC- Standard of Care Adjuvant Chemotherapy
Randomised to Arm A: Standard of Care Arm (Patients with fully resected high risk stage II or stage III colon or Rectal cancer with no evidence of metastatic disease. Patients with locally advanced rectal cancer who have previously undergone chemoradiotherapy are also eligible to enrol.
No interventions assigned to this group
Part C-ct DNA Guided Arm
Patients with fully resected high risk stage II or stage III colon or rectal cancer with no evidence of metastatic disease. Patients with locally advanced rectal cancer who have previously undergone chemoradiotherapy are also eligible to enrol.
De-escalation of adjuvant chemotherapy in patients who have a post-operative ctDNA negative result
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients with high grade dysplasia whose imaging is suggestive of colorectal carcinoma (CRC) will be included but will be excluded post-surgery if carcinoma diagnosis is not confirmed
* Age≥18
* Ability to give informed consent
* Able to adhere to follow up schedule
1. Subject ≥ 18 years of age
2. Subjects with histologically proven high risk stage II or stage III colon or rectal cancer treated with curative intent with surgery alone (any T, N1 or N2) with no evidence of metastatic disease. High risk stage II is defined as having one or more of the following: T4 disease, obstruction and/or perforation of the primary tumour during the pre-operative period, inadequate nodal harvest as indicated by \<12 nodes examined, poorly differentiated grade on histology, perineural invasion, peritoneal involvement or extramural venous/lymphatic invasion. Subjects must be due to receive adjuvant chemotherapy after surgery or Subjects with histologically proven locally advanced stage III rectal cancer treated with neoadjuvant chemoradiotherapy (any T, N1 or N2, M0) with no evidence of metastatic disease are eligible. Subjects must be due to receive adjuvant chemotherapy after surgery
3. Fully surgically resected tumour with clear resection margins (i.e., \>1 mm).
4. Adequate organ function
* Absolute neutrophil function ≥1.0 x 109/ L
* Platelet Count ≥ 75 x 109 / L
* Haemoglobin ≥80g/L (blood transfusion before randomisation is allowed)
* Adequate renal function (GFR ≥ 50ml/min if single agent capecitabine or CAPOX being administered) as calculated by Cockcroft and Gault equation
* Aspartate aminotransferase/ Alanine aminotransferase levels ≤ 2.5 upper limit of normal
5. Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy
6. Patients should be assessed by Oncology team for suitability and assessment for adjuvant chemotherapy, be able to have post-operative ctDNA sample collected and be randomised by week 8 ± 2 weeks after surgery.
7. ECOG performance status 0- 2
8. Able to give informed consent
Exclusion Criteria
* Current or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix or other non-invasive malignancy
TRACC Part C
1\. History of concurrent and previous malignancy within the last 5 years, with the exception of non- melanomatous skin cancer and carcinoma in situ 2. Any major post-operative complications or other clinical conditions that in the opinion of the investigator would contra-indicate adjuvant chemotherapy 3. Any subject not due to receive adjuvant chemotherapy will not be eligible for Part C of the study 4. Hypersensitivity or contraindication to the drug(s) associated with the planned choice of systemic chemotherapy (CAPOX or single agent capecitabine) as stated in the SmPC for each of the drugs 5. Subjects due to receive 5-Flurouracil (5-FU) based adjuvant chemotherapy (either single agent 5-FU or in combination with oxaliplatin) will not be eligible for Part C of the study
\-
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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David Cunningham
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Milton Keynes General Hospital
Milton Keynes, Buckinghamshire, United Kingdom
Croydon University Hospital
Thornton Heath, Croydon, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, United Kingdom
Poole Hospital
Poole, Dorset, United Kingdom
Broomfield Hospital
Chelmsford, Essex, United Kingdom
Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom
Epsom and St Helier's Hospitals NHS Trust
Carshalton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Guy's & St Thomas Hospital
London, UK, United Kingdom
Bradford Royal Infirmary
Bradford, West Yorkshire, United Kingdom
Salisbury District Hospital
Salisbury, Whiltshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Bronglais Hospital
Aberystwyth, , United Kingdom
Stoke Mandeville Hospital
Aylesbury, , United Kingdom
Basildon and Thurrock University Hospitals
Basildon, , United Kingdom
Basingstoke and North Hampshire Hospitals
Basingstoke, , United Kingdom
Bedford Hospital
Bedford, , United Kingdom
Royal Blackburn Teaching Hospital
Blackburn, , United Kingdom
Pilgrim Hospital
Boston, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Burnley General Teaching Hospital
Burnley, , United Kingdom
West Suffolk Hospital
Bury, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
North Cumbria University Hospitals
Carlisle, , United Kingdom
Glangwili Hospital
Carmarthen, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, , United Kingdom
Leighton Hospital
Crewe, , United Kingdom
University Hospital Crosshouse
Crosshouse, , United Kingdom
Medway NHS Foundation Trust
Gillingham, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Princess Alexandra Hospital NHS Trust
Harlow, , United Kingdom
Withybush General Hospital
Haverfordwest, , United Kingdom
Wycombe Hospital
High Wycombe, , United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, , United Kingdom
Airedale General Hospital
Keighley, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
Kingston Hospital Foundation Trust
Kingston upon Thames, , United Kingdom
Forth Valley Royal Hospital
Larbert, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Prince Philip Hospital
Llanelli, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
North Middlesex University Hospital NHS Trust
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St George's NHS Foundation Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust - London
London, , United Kingdom
Chelsea and Westminster
London, , United Kingdom
Maidstone & Tunbridge Wells NHS Trust
Maidstone, , United Kingdom
Chase Farm Hospital
Middlesex, , United Kingdom
Northampton General Hospital NHS Trust
Northampton, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
George Eliot Hospital
Nuneaton, , United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals
Preston, , United Kingdom
Barking Havering and Redbridge NHS Foundation Trust (Queen's Hospital
Romford, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
South Tyneside District Hospital
South Shields, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Stockport NHS Foundation Trust
Stockport, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
King's Mill Hospital
Sutton in Ashfield, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, , United Kingdom
Royal Hampshire County Hospital
Winchester, , United Kingdom
Countries
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Central Contacts
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Susie Slater, Dr
Role: CONTACT
Facility Contacts
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Sarah Duff
Role: primary
Graham Branagan
Role: primary
Venkatesh Gajapathy
Role: primary
References
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Slater S, Bryant A, Aresu M, Begum R, Chen HC, Peckitt C, Lazaro-Alcausi R, Carter P, Anandappa G, Khakoo S, Melcher L, Potter V, Marti FM, Huang J, Branagan G, George N, Abulafi M, Duff S, Raja A, Gupta A, West N, Bucheit L, Rich T, Chau I, Cunningham D, Starling N; TRACC Part B trial investigators. Tissue-Free Liquid Biopsies Combining Genomic and Methylation Signals for Minimal Residual Disease Detection in Patients with Early Colorectal Cancer from the UK TRACC Part B Study. Clin Cancer Res. 2024 Aug 15;30(16):3459-3469. doi: 10.1158/1078-0432.CCR-24-0226.
Slater S, Bryant A, Chen HC, Begum R, Rana I, Aresu M, Peckitt C, Zhitkov O, Lazaro-Alcausi R, Borja V, Powell R, Lowery D, Hubank M, Rich T, Anandappa G, Chau I, Starling N, Cunningham D. 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). BMC Cancer. 2023 Mar 20;23(1):257. doi: 10.1186/s12885-023-10699-4.
Other Identifiers
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CCR4344
Identifier Type: -
Identifier Source: org_study_id
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