Trial Information
Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
The criteria for application of RCT is the distance of the tumor from mesorectal fascia in
preoperative MRI of the pelvis. In case of a T 4 tumor or a tumor with a distance of 1mm of
less form mesorectal fascia long-course radiochemotherapy is applied followed by surgery, in
all other cases primary surgery is done.
Inclusion Criteria:
- Patients with histologically confirmed invasive carcinoma of the rectum infiltrating
beyond the submucosa (cT3, cT2N+, cM0)
- Elective surgery
- Fit for surgery
- Preoperative MRI of pelvis
Exclusion Criteria:
- uT1 Tumors
- provided for local excision
- previous or synchronous malignant tumors (except squamous and basal cell carcinoma of
the skin and carcinoma in situ of the cervix)
- previous irradiation of the pelvis
- ulcerative colitis or Crohn's disease
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Locoregional recurrence rate
Outcome Time Frame:
Five year
Safety Issue:
No
Authority:
Ethic committee Rheinland Pfalz: Mainz/Germany
Study ID:
Ocumstudy 19.08.2009
NCT ID:
NCT01325649
Start Date:
February 2009
Completion Date:
December 2015
Related Keywords:
- Rectal Cancer Stage II
- Rectal Cancer Stage III
- rectal cancer
- MRI
- selective preoperative radiochemotherapy
- involvement of circumferential resection margin
- locoregional recurrence rate
- Carcinoma
- Rectal Neoplasms