TRACC C

Tracking mutations in cell free tumour DNA to predict Relapse in Early Colorectal Cancer (Part C Only)

For patients in the ctDNA guided interventional arm of the study only (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. Subjects must be due to receive adjuvant chemotherapy following surgery.

Subjects with histologically proven stage III rectal cancer are eligible, including patients treated with neoadjuvant chemoradiotherapy (any T, N1 or N2, M0) with no evidence of metastatic disease. Subjects must be due to receive adjuvant chemotherapy following surgery.

3. Fully surgically resected tumour with clear resection margins (i.e., >1 mm)

4. Patients must have detectable levels of ctDNA (i.e., ctDNA positive) in blood samples at baseline; this is collected pre-operatively if being treated with surgery alone, or before chemoradiotherapy in patients with locally advanced rectal cancer being treated with neoadjuvant chemoradiotherapy before surgery

5. 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 as calculated by Cockcroft and Gault equation (GFR  30ml/min if FOLFOX chemotherapy chosen and GFR  50ml/min if single agent capecitabine or CAPOX chosen)

- Aspartate aminotransferase/ Alanine aminotransferase levels  2.5 upper limit of normal

6. Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would not contraindicate adjuvant chemotherapy

7. 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 4-8 after surgery.

8. ECOG performance status 0- 2

9. Able to give informed consent 

For patients in the ctDNA guided interventional arm of the study only (Part C)

Exclusion Criteria:

1. History of concurrent and previous malignancy within the last 3 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, FOLFOX or single agent 5-FU or capecitabine) as stated in the SPC for each of the drugs 

Lead Research Nurse: Sarah Keith (sarah.keith@elht.nhs.uk)

Administrator: Oncology Research Team