Follow up and functional outcome of organ saving treatment in patients with good response to neo-adjuvant (chemo)radiatio

Completed

• Conditions: colorectal cancer; rectal neoplasm; 10017990; 10017991; 10017998

• Registration Number: NL-OMON44162
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

*1. > 18 years old
2. Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
2A. Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
2B. Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor
3. Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
4. Choosing for the organ-saving treatment option (wait&see policy or TEM)
5. Informed consent

Exclusion Criteria

1. Unable to understand or read Dutch
2. Unwilling to comply to the questionnaires or manometric measurement.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Functional outcome scores of patients that are treated with an organ saving<br /><br>strategy compared to patients who undergo the standard resection as described<br /><br>in literature. Functional outcome will be evaluated with questionnaires<br /><br>(quality of life).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Cumulative risk of local failure within 5 years<br /><br>* Cumulative risks of disease-free, distant-metastasis free and overall<br /><br>survival within 5 years<br /><br>* The percentage of patients that choose the alternative strategies instead of<br /><br>traditional strategies and the motivation for their choice<br /><br>* The compliance to the intensive follow-up schedule<br /><br>* Early detection of local failure (standard surgery still possible)</p><br>