Status:
COMPLETED
Minimal Invasive Strategies for Good and Complete Response to Chemoradiation in Rectal Cancer
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whet...
Detailed Description
The high proportion of complete and good responders with modern chemoradiation and the improvement in magnetic resonance (MR)-imaging techniques have stimulated a renewed interest to the question whet...
Eligibility Criteria
Inclusion
- 18 years or older
- Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response: Clinical complete response (ycT0N0) or very good response (ycT1-2N0) after pre-operative chemoradiation will be determined clinically (digital rectal examination, endoscopy), radiologically (contrast-enhanced-MRI) and pathologically (biopsy)
- Informed consent and capability of giving informed consent
- Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient (in other words that the patient understands the experimental base of the study).
Exclusion
- Recurrent rectal cancer.
- Distant metastasis.
- Unable or unwilling to comply to the intensive follow-up schedule.
- Contra-indications for MRI. If MRI is not possible because of contra-indications (e.g. pacemaker) we will exclude patients. MRI is crucial for response evaluation and follow-up and can not be omitted in patients that follow the alternative strategies ('wait-and-see policy' or TEM).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00939666
Start Date
July 1 2009
End Date
September 1 2014
Last Update
March 24 2017
Active Locations (2)
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1
Maastricht University Medical Center
Maastricht, Netherlands
2
Laurentius Hospital Roermond
Roermond, Netherlands