Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma

Rectal Cancer Stage III Clinical Trial

— OCUM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325649
• Other study ID #: Ocumstudy 19.08.2009
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: October 18, 2016
• Start date: February 2009
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethic committee Rheinland Pfalz: Mainz/Germany
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1051
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rectal Cancer Stage II
• Rectal Cancer Stage III
• Rectal Neoplasms

Intervention

Procedure:
• total mesorectal excision / long course radiochemotherapy
long course 5-FU based radiochemotherapy before total mesorectal excision

Radiation:
• long course 5-FU bases radiochemotherapy

Locations

Country	Name	City	State
Germany	University Medicine Center Department of General and Abdomial Surgery	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional recurrence rate		Five year	No
Secondary	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	Yes