A study on the response to neoadjuvant chemotherapy per CMS subtype in patients with colon cancer
- Conditions
- Colon cancer
- Registration Number
- NL-OMON26611
- Lead Sponsor
- Alpe d'huzes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 262
Patients are eligible when they meet the following criteria:
•Patient is able and willing to provide written informed consent for the CONNECTION- study
•Informed consent signed for PLCRC components ‘clinical data’ 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
•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 of less than 5%
•Colonic obstruction that cannot be defunctioned by a stoma
•Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the pathological tumour response to neoadjuvant chemotherapy per CMS subtype.
- Secondary Outcome Measures
Name Time Method •Pathological tumour response (Modified Ryan scheme; Ki-67, Caspase-3 and cytostatic-cytotoxic effects on HE-stained tissue slides) <br>•Radiological tumour response to neoadjuvant chemotherapy per CMS subtype. <br>•Recurrence free survival at two and three years <br>•Therapy-induced CMS differences. <br><br>•Prognostic and predictive value of cytotoxic lymphocytes (CytoLym) and cancer-associated fibroblasts (CAF) infiltration scores. <br>•Diagnostic accuracy of ctDNA measurements for monitoring treatment response to neoadjuvant treatment and detection of residual disease. <br>•Percentages of pathological complete (R0), pathological microscopic incomplete (R1) and pathologically macroscopic incomplete (R2) resections. <br>•Surgical complication rate (i.e. wound infections and anastomotic leak)<br>