Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer
Recruiting · NCT04050345 · Observational (researchers observe without assigning treatment) · Lead sponsor: Royal Marsden NHS Foundation Trust
View the official record on ClinicalTrials.gov →What this trial is about
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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:
- Subject ≥ 18 years of age
- 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
- Fully surgically resected tumour with clear resection margins (i.e., \>1 mm).
- 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
- Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy
- 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.
- ECOG performance status 0- 2
- Able to give informed consent
- TRACC Part C Exclusion criteria
- \. 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
Where it is running
60 locations listed.
- 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
- 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
Showing 60 of 71 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →