Study population
CRC, ® whole blood, malignancy, perforation, colon or rectal cancer, Hypersensitivity, tumour, skin cancer, T4 disease
HYPERSENSITIVITY, METASTATIC DISEASE, TUMOUR, SKIN CANCER, CARCINOMA IN SITU, ONCOLOGY, RECTAL CANCER, COMPLICATIONS
Patients are eligible if they are 18 years or over, have histologically proven high risk stage II or stage II CRC that has been fully resected with clear margins (> 1 mm), Eastern Cooperative Oncology Group (ECOG) PS 0–2 and able to give informed consent. Patients must have adequate organ function as determined by routine full blood count and biochemistry blood tests, and no evidence of metastatic disease on pre- or post-operative imaging, with the absence of major post-operative complications. Patients should be assessed by an oncology team and deemed suitable for treatment with ACT, having a post-operative blood sample for ctDNA collected 4–8 (+ 2) weeks after surgery in four 10.0 ml Streck cfDNA BCT® whole blood collection tubes and commencing ACT within 12 weeks. The inclusion and exclusion criteria are outlined in Table TRACC Part C eligibility criteria1. Subject ≥ 18 years of age2. 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, tumour 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 following surgerySubjects with histologically proven locally advanced 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 following surgery3. Fully surgically resected tumour (R0) with clear resection margins (i.e., > 1 mm)4. Adequate organ function- Absolute neutrophil function ≥ 1.0 × 10- Platelet Count ≥ 75 × 10- Haemoglobin ≥ 80 g/L (blood transfusion before randomisation is allowed)- Adequate renal function as calculated by Cockcroft and Gault equation (GFR ≥ 50 ml/min if single agent capecitabine or CAPOX being administered)- Aspartate aminotransferase/ Alanine aminotransferase levels ≤ 2.5 upper limit of normal5. Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would not contraindicate adjuvant chemotherapy6. 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 (± 2 weeks) after surgery and commence adjuvant chemotherapy within 12 weeks after surgery7. ECOG performance status 0- 28. Able to give informed consent1. History of concurrent and previous malignancy within the last 5 years, with the exception of non- melanomatous skin cancer and carcinoma in situ2. Any major post-operative complications or other clinical conditions that in the opinion of the investigator would contra-indicate adjuvant chemotherapy3. Any subject not due to receive adjuvant chemotherapy will not be eligible for Part C of the study4. Hypersensitivity or contraindication to the drug(s) associated with the planned choice of systemic chemotherapy (CAPOX or capecitabine) as stated in the Summary of Product Characteristics (SmPC) for each of the drugs5. Subjects due to receive 5-flurouracil (5FU) based adjuvant chemotherapy (either single agent 5FU or in combination with oxaliplatin) will not be eligible for Part C of the study, these patients will continue to be followed in the observational Part B of the studyECOG performance status, Eastern Cooperative Oncology Group performance status