Colon cancer
Conditions
Interventions
neoadjuvant CAPOX
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all the following criteria: • Histologically proven cT3-4, N0-2, M0 primary colon cancer, patients with rectal cancer will be excluded from this study. If there is uncertainty about the origin of the carcinoma (i.e. colon or rectum), it is up to the local treating physician to decide whether the patient is eligible. For tumours located in the rectosigmoid region, the decision of the local multidisciplinary team will determine if a patient is eligible for this study. • ?18 years • Patient is able and willing to provide written informed consent for the CONNECTION- study • Informed consent for PLCRC components ‘clinical data’, ‘tissue’ and ‘future studies’ • MSS based on pre-treatment biopsy by IHC • Fit to undergo neoadjuvant chemotherapy with capecitabine + oxaliplatin and subsequent surgery judged by the primary treating physician • Adequate bone marrow, liver and renal function - absolute neutrophil count (ANC) =1.5 x 109/L - platelets =100 x 109/L - HB = 5.5 mmol/L - Total bilirubin = 1.5 UNL - ASAT = 5 x UNL - ALAT = 5 x UNL - alkaline phosphatase = 5 x UNL - creatinine clearance >30 ml/min
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Any other malignant disease within the preceding 5 years apart from non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <5% • Colonic obstruction that has not been defunctioned by a stoma • Pregnant or lactating women
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of the radiological tumour response to neoadjuvant systemic chemotherapy per CMS subtype. • Assessment of prognostic value of pathological and radiological response to neoadjuvant systemic therapy for recurrence free survival (RFS) at three years. • Assessment of differences in CMS classification before and after neoadjuvant systemic therapy. • Assessment of pathologic response by Ki-67, Caspase-3 and cystatic-cytotoxic effects on HE-stained tissue slides. • Evaluation of diagnostic accuracy of ctDNA measurements for monitoring treatment response to neoadjuvant treatment and detection of residual disease. | — |
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the pathological tumour response to neoadjuvant systemic chemotherapy per CMS subtype in patients with microsatellite stable high risk stage II and stage III colon cancer. | — |
Contacts
Public ContactInge van den Berg
Erasmus MC
Outcome results
None listed