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RECRUITING

NCT04050345

Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

Sponsor: Royal Marsden NHS Foundation Trust

View on ClinicalTrials.gov

Summary

TRACC Part B This is a multi-centre, prospective, translational research study involving the collection and analysis of tumour tissue, serial blood samples and clinical data in patients with newly diagnosed stage I, II and III CRC. 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2016-12-05

Completion Date

2031-07-31

Last Updated

2024-06-14

Healthy Volunteers

Conditions

Colorectal Cancer

TRACC Part B Inclusion Criteria: * New diagnosis of histologically confirmed CRC scheduled to undergo surgery with curative intent, with no radiological evidence of metastatic disease. * 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 TRACC Part B Exclusion Criteria: * Scheduled to have neoadjuvant chemotherapy, (neoadjuvant chemoradiotherapy for patients with rectal cancer is permitted) * 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 Inclusion Criteria: 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 TRACC Part C Exclusion criteria 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 \-

Locations (71)

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

Clinical Research Directory

Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

Summary

Key Details

Conditions

Eligibility Criteria

Locations (71)