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

Recruiting now

Conditions studied: Colorectal Cancer

In brief

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 facts

Study ID

NCT04050345

Run by

Royal Marsden NHS Foundation Trust

People needed

1000

Starts

2016-12-05

Expected to finish

2031-07-31

Last updated by the study team

2024-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

• Milton Keynes General Hospital — Milton Keynes, Buckinghamshire, United Kingdom (enrolling)
• Dorset County Hospital NHS Foundation Trust — Dorchester, Dorset, United Kingdom (enrolling)
• Poole Hospital — Poole, Dorset, United Kingdom (enrolling)
• Croydon University Hospital — Thornton Heath, Croydon, United Kingdom (enrolling)
• Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (enrolling)
• Queen Alexandra Hospital — Portsmouth, Hampshire, United Kingdom (enrolling)
• University Hospital of South Manchester & Manchester Royal Infirmary — Wythenshawe, Manchester, United Kingdom (enrolling)
• Musgrove Park Hospital — Taunton, Somerset, United Kingdom (enrolling)
• Weston General Hospital — Weston-super-Mare, Somerset, United Kingdom (enrolling)
• Broomfield Hospital — Chelmsford, Essex, United Kingdom (enrolling)
• The Royal Marsden NHS Foundation Trust — Sutton, Surrey, United Kingdom (enrolling)
• Guy's & St Thomas Hospital — London, UK, United Kingdom (enrolling)
• Bradford Royal Infirmary — Bradford, West Yorkshire, United Kingdom (enrolling)
• Salisbury District Hospital — Salisbury, Whiltshire, United Kingdom (enrolling)
• Aberdeen Royal Infirmary — Aberdeen, United Kingdom (enrolling)
• Bronglais Hospital — Aberystwyth, United Kingdom (enrolling)
• Stoke Mandeville Hospital — Aylesbury, United Kingdom (enrolling)
• Basildon and Thurrock University Hospitals — Basildon, United Kingdom (enrolling)
• Basingstoke and North Hampshire Hospitals — Basingstoke, United Kingdom (enrolling)
• Bedford Hospital — Bedford, United Kingdom (enrolling)
• Royal Blackburn Teaching Hospital — Blackburn, United Kingdom (enrolling)
• Pilgrim Hospital — Boston, United Kingdom (enrolling)
• Royal Bournemouth Hospital — Bournemouth, United Kingdom (enrolling)
• University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom (enrolling)
• Burnley General Teaching Hospital — Burnley, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.