*Improving clinical management of colon cancer through CONNECTION, a nation-wide Colon Cancer Registry and Stratification effort.*
- Conditions
- Colon carcinoma. colon cancer1001799010017998
- Registration Number
- NL-OMON53082
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 262
• 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
• 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 can not be defunctioned by a stoma
• Patients presenting with a stricturing tumour unable to pass with the scope
• Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is pathological response according to the tumour response<br /><br>grading (TRG) classification described by Dworak. In the Dworak system, good to<br /><br>complete responders are defined as TRG2+TRG3+TRG4; bad responders are defined<br /><br>as Dworak TRG1+TRG0.</p><br>
- Secondary Outcome Measures
Name Time Method