Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1051 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2016-09-30

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.

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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.

Conditions

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Rectal Cancer Stage II Rectal Cancer Stage III

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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advanced rectal cancer

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

total mesorectal excision / long course radiochemotherapy

Intervention Type PROCEDURE

long course 5-FU based radiochemotherapy before total mesorectal excision

long course 5-FU bases radiochemotherapy

Intervention Type RADIATION

Interventions

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total mesorectal excision / long course radiochemotherapy

long course 5-FU based radiochemotherapy before total mesorectal excision

Intervention Type PROCEDURE

long course 5-FU bases radiochemotherapy

Intervention Type RADIATION

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No