Can we use a simple blood test to reduce patients who will receive neoadjuvant chemoradiation by timely identification of radiotherapy-resistant rectal cancers?

• Conditions: Rectal cancer; 10017990; rectal malignancy

• Registration Number: NL-OMON53879
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

- Age >18 - Histologically confirmed rectal adenocarcinoma - Scheduled for
neoadjuvant chemoradiation

Exclusion Criteria

- Scheduled to another neoadjuvant schedule that comprises systemic
chemotherapy or short-course radiation
- Not able to read or understand Dutch language or mentally incompetent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pathological response rate (percentage necrosis in comparison to tumour cells<br /><br>in the resected specimen) after CRT, determined by an expert pathologist<br /><br>according to the Mandard Tumour Regression Grade (TRG).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>cfDNA methylation profiling and molecular characteristics of the tumour tissue.<br /><br>Clinical features and molecular characteristics of patients with a clinical<br /><br>complete reponse. The analyses of this tissue will be as described above for<br /><br>the other tissue but this group will be investigated separately.</p><br>