A study on the response to neoadjuvant chemotherapy per CMS subtype in patients with colon cancer

Improving clinical management of colon cancer through CONNECTION, a nation-wide Colon Cancer Registry and Stratification effort

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26611

Enrollment

262

Registered

2019-11-21

Start date

2019-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

2 courses of neoadjuvant CAPOX

Eligibility

Inclusion criteria

Inclusion criteria: 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

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 of less than 5% • Colonic obstruction that cannot be defunctioned by a stoma • Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the pathological tumour response to neoadjuvant chemotherapy per CMS subtype.	—

Secondary

Measure	Time frame
• Pathological tumour response (Modified Ryan scheme; Ki-67, Caspase-3 and cytostatic-cytotoxic effects on HE-stained tissue slides) • Radiological tumour response to neoadjuvant chemotherapy per CMS subtype. • Recurrence free survival at two and three years • Therapy-induced CMS differences. • Prognostic and predictive value of cytotoxic lymphocytes (CytoLym) and cancer-associated fibroblasts (CAF) infiltration scores. • Diagnostic accuracy of ctDNA measurements for monitoring treatment response to neoadjuvant treatment and detection of residual disease. • Percentages of pathological complete (R0), pathological microscopic incomplete (R1) and pathologically macroscopic incomplete (R2) resections. • Surgical complication rate (i.e. wound infections and anastomotic leak)	—

Measure

Time frame

• Pathological tumour response (Modified Ryan scheme; Ki-67, Caspase-3 and cytostatic-cytotoxic effects on HE-stained tissue slides) • Radiological tumour response to neoadjuvant chemotherapy per CMS subtype. • Recurrence free survival at two and three years • Therapy-induced CMS differences. • Prognostic and predictive value of cytotoxic lymphocytes (CytoLym) and cancer-associated fibroblasts (CAF) infiltration scores. • Diagnostic accuracy of ctDNA measurements for monitoring treatment response to neoadjuvant treatment and detection of residual disease. • Percentages of pathological complete (R0), pathological microscopic incomplete (R1) and pathologically macroscopic incomplete (R2) resections. • Surgical complication rate (i.e. wound infections and anastomotic leak)

—

Contacts

Public ContactInge van den Berg

Erasmus MC

i.vandenberg@erasmusmc.nl0646440430

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)