Minimal Invasive Treatment for Patients With Good Response to Chemoradiation With Selection and Follow-up by MRI: a Single Arm Phase-II Feasibility Study in Rectal Cancer
- 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).
- 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).