NCT01325649
Completed
Not Applicable
Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
Johannes Gutenberg University Mainz1 site in 1 country1,051 target enrollmentFebruary 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer Stage II
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 1051
- Locations
- 1
- Primary Endpoint
- Locoregional recurrence rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The objective of the study is to provide proof that a MRI based preoperative radiochemotherapy in patients with locally advanced rectal carcinoma allows limiting RCT to high risk patients without increase of locoregional recurrence rate and decrease of overall survival provided there is a high quality of mesorectal excision.
Detailed Description
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.
Investigators
Theo Junginger
MD
Johannes Gutenberg University Mainz
Eligibility Criteria
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
Outcomes
Primary Outcomes
Locoregional recurrence rate
Time Frame: Five year
Secondary Outcomes
- Rate of involvement of circumferential resection margin (pCRM positive of resected specimens(postoperative)
Study Sites (1)
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