Trials / Completed
CompletedNCT01325649
Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma
Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,051 (actual)
- Sponsor
- Johannes Gutenberg University Mainz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | total mesorectal excision / long course radiochemotherapy | long course 5-FU based radiochemotherapy before total mesorectal excision |
| RADIATION | long course 5-FU bases radiochemotherapy |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2011-03-30
- Last updated
- 2016-10-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01325649. Inclusion in this directory is not an endorsement.