C20
Conditions
Interventions
Group 1: TME (total mesorectal excision): open or minimally-invasive surgery (laparoscopic or robotic) in terms of low anterior resection or abdomino-perineal resection with dissection of the rectum a
duration: 3-6h.
Group 2: Guideline-compliant neoadjuvant (chemo)radiotherapy (n(C)RT) according to the German S3-guideline followed by open or minimally-invasive surgery (laparoscopic or robotic) in t
Sponsors
Universitätsklinikum Heidelberg; Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Primary adenocarcinoma of the rectum 1mm (MRI based) - No evidence of distant metastasis (M0) - Age =18 years - Ability of patient subject to understand character and individual consequences of the clinical trial - Written informed consent
Exclusion criteria
Exclusion criteria: - Patients who should not receive multimodal treatment for safety reasons - Patients needing neoadjuvant treatment for sphincter preservation - Previous radiotherapy to the small pelvis - Patients with extensive lymph node spread (N2) - Extramural vascular invasion or tumour deposits - Participation in another interventional trial with interference of intervention and/or outcome of this trial - Previous diagnosis of malignant disease within 5 years prior to current disease except basal cell carcinomaa - Contraindications for MRI (e.g. non-MRI-compatible cardiac pacemaker) - Pregnancy or lactation - Any condition that could result in an undue risk for the patient based on the investigator’s assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local recurrence within three years after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Major low anterior resection syndrome (LARS), overall survival, disease-free survival, local-recurrence-free survival, distant-metastases-free survival, acute toxicity of (chemo)radiotherapy, perioperative morbidity, perioperative mortality, length of hospital stay, course of tumour markers, quality of life, functional scores (urinary and sexual) | — |
Countries
Germany, Switzerland
Contacts
Public ContactRosa Klotz
Universitätsklinikum Heidelberg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed