Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma

Completed

• Conditions: Rectal Cancer Stage II; Rectal Cancer Stage III
• Interventions: Procedure: total mesorectal excision / long course radiochemotherapy; Radiation: long course 5-FU bases radiochemotherapy

• Registration Number: NCT01325649
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1051

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
advanced rectal cancer	total mesorectal excision / long course radiochemotherapy	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
advanced rectal cancer	long course 5-FU bases radiochemotherapy	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

Primary Outcome Measures

Name	Time	Method
Locoregional recurrence rate	Five year

Secondary Outcome Measures

Name	Time	Method
Rate of involvement of circumferential resection margin (pCRM positive of resected specimens	postoperative	pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less.

Trial Locations

Locations (1)

University Medicine Center Department of General and Abdomial Surgery; 🇩🇪 Mainz, Germany