Status:
UNKNOWN
Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.
Detailed Description
Rectal cancer is a common form of cancer. Standard treatment for locally advanced rectal cancer is a long course of neoadjuvant radiation combined with chemotherapy (CRT) followed by resection. Howeve...
Eligibility Criteria
Inclusion
- 18 years old
- Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response :
- Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI)
- 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
- Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient
- Choosing for the organ-saving treatment option (wait\&see policy or TEM)
- Informed consent
Exclusion
- Unable to understand or read Dutch
- Unwilling to comply to the questionnaires or manometric measurement.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02278653
Start Date
March 1 2014
End Date
September 1 2022
Last Update
September 18 2019
Active Locations (1)
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1
MUMC+
Maastricht, Netherlands, 6202 AZ