Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma (OCUM)

This study is currently recruiting participants.
Verified March 2011 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01325649
First received: March 28, 2011
Last updated: March 29, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Rectal Cancer Stage II
Rectal Cancer Stage III
Procedure: total mesorectal excision

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Locoregional recurrence rate [ Time Frame: Five year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of involvement of circumferential resection margin (pCRM positive of resected specimens [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]
    pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less.


Estimated Enrollment: 782
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
advanced rectal cancer
Patients with carcinoma of the middle rectum with positive mrCRM (≤ 1 mm), with cT3 low rectal carcinoma, and with cT4 tumors
Procedure: total mesorectal excision
long course 5-FU based radiochemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with carcinoma of the middle rectum with positive mrCRM (≤ 1 mm), with cT3 low rectal carcinoma, and with cT4 tumors

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325649

Contacts
Contact: Theo Junginger, MD 049 6131 17 41 68 Junginger@uni-mainz.de

Locations
Germany
University Medicine Center Department of General and Abdomial Surgery Recruiting
Mainz, Germany, 55131
Contact: Theo Junginger, MD    049 6131 17 41 68    junginger@uni-mainz.de   
Contact: Susanne Merkel, MD    049 9131 85 33 101    susanne.merkel@uk-erlangen.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

No publications provided

Responsible Party: Theo Junginger MD, Department of General and Abdominal Surgery, University Medicine Centre Mainz/Germany
ClinicalTrials.gov Identifier: NCT01325649     History of Changes
Other Study ID Numbers: Ocumstudy 19.08.2009
Study First Received: March 28, 2011
Last Updated: March 29, 2011
Health Authority: Ethic committee Rheinland Pfalz: Mainz/Germany

Keywords provided by Johannes Gutenberg University Mainz:
rectal cancer
MRI
selective preoperative radiochemotherapy
involvement of circumferential resection margin
locoregional recurrence rate

Additional relevant MeSH terms:
Carcinoma
Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 17, 2014