Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma

Conditions
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Rectal Cancer Stage II, Rectal Cancer Stage III

Intervention / Treatment
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* Procedure: total mesorectal excision / long course radiochemotherapy
* Radiation: long course 5-FU bases radiochemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| advanced rectal cancer<br>Patients with carcinoma of the middle rectum with positive mrCRM (≤ 1 mm), with cT3 low rectal carcinoma, and with cT4 Tumors Arm 1 Long course radiochemotherapy before total mesorectal excision Arm 2 total mesorectal excision without radiochemotherapy | Procedure: total mesorectal excision / long course radiochemotherapy<br>* long course 5-FU based radiochemotherapy before total mesorectal excision<br>Radiation: long course 5-FU bases radiochemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional recurrence rate |  | Five year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of involvement of circumferential resection margin (pCRM positive of resected specimens | pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less. | postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, MRI, selective preoperative radiochemotherapy, involvement of circumferential resection margin, locoregional recurrence rate