Colon carcinoma. colon cancer
Conditions
Interventions
2 courses neo-adjuvant en 2 courses adjuvant capecitabine and oxaliplatin
(CAPOX)
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Histologically proven cT3-4, N0-2, M0 primary colon cancer • >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 and subsequent surgery judged by the primary treating physician • Adequate full blood count, renal biochemistry and hepatobiliary function
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is pathological response according to the tumour response grading (TRG) classification described by Dworak. In the Dworak system, good to complete responders are defined as TRG2+TRG3+TRG4; bad responders are defined as Dworak TRG1+TRG0. | — |
Secondary
| Measure | Time frame |
|---|---|
| • In addition to the primary endpoint, the pathological response will be evaluated per TRG category separately for the different CMS subtypes and per Tumor Regression Score (TRS) following the Modified Ryan scheme (TRS 0, 1, 2, 3). [11] • Percentages of pathological complete (R0), pathological microscopic incomplete (R1) and pathologically macroscopic incomplete (R2) will be analysed. • Radiological response after neoadjuvant chemotherapy in relation to CMS subtypes. Radiological response of the tumour will be evaluated by measuring the sum of diameters of the primary tumour, and reported as a continuous outcome measure. • RFS at two and three years, RFS is defined as the time elapsed between the diagnosis of the primary tumour and either the date of any recurrence of disease, time of death, or the date of the last follow-up visit at which a patient was considered to have no recurrence. • Therapy-induced CMS differences. The CMS classification will be performed based on RNA expression profiles. • Pathologic response will be measured by comparing the pre-treatment biopsies with the resected material by checking regression of Ki-67 (cell cycle) and increased levels of activated Caspase-3 (apoptosis) along with HE staining for cytostatic or cytotoxic effects. • Prognostic and predictive value of cytotoxic lymphocytes (CytoLym) and cancer-associated fibroblasts (CAF) infiltration scores. • Evaluation of diagnostic accuracy of ctDNA measurements for monitoring treatment response to neoadjuvant treatment and detection of residual disease. • Data on surgical complications (i.e. wound infections and anastomotic leak) will be recorded and collected. The complication rate in this study cohort will be compared with the general complication rate of patients who did not receive preoperative chemotherapy, and with the final results of the FOXTROT study. Exploratory study parameters/endpoints To optimize the clinical staging of patients with colon can | — |
Countries
Netherlands
Outcome results
None listed