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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01325649
First Posted: March 30, 2011
Last Update Posted: October 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theo Junginger, Johannes Gutenberg University Mainz
  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 / long course radiochemotherapy Radiation: long course 5-FU bases radiochemotherapy

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

Further study details as provided by Theo Junginger, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Locoregional recurrence rate [ Time Frame: Five year ]

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


Enrollment: 1051
Study Start Date: February 2009
Study Completion Date: September 2016
Primary Completion Date: September 2016 (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 Arm 1 Long course radiochemotherapy before total mesorectal excision Arm 2 total mesorectal excision without radiochemotherapy
Procedure: total mesorectal excision / long course radiochemotherapy
long course 5-FU based radiochemotherapy before total mesorectal excision
Radiation: long course 5-FU bases 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325649


Locations
Germany
University Medicine Center Department of General and Abdomial Surgery
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theo Junginger, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01325649     History of Changes
Other Study ID Numbers: Ocumstudy 19.08.2009
First Submitted: March 28, 2011
First Posted: March 30, 2011
Last Update Posted: October 19, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases