- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01325649
Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma (OCUM)
October 18, 2016 updated by: Theo Junginger, Johannes Gutenberg University Mainz
Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1051
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mainz, Germany, 55131
- University Medicine Center Department of General and Abdomial Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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long course 5-FU based radiochemotherapy before total mesorectal excision
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Locoregional recurrence rate
Time Frame: Five year
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Five year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of involvement of circumferential resection margin (pCRM positive of resected specimens
Time Frame: postoperative
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pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less.
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postoperative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ruppert R, Kube R, Strassburg J, Lewin A, Baral J, Maurer CA, Sauer J, Junginger T, Hermanek P, Merkel S; other members of the OCUM Group. Avoidance of Overtreatment of Rectal Cancer by Selective Chemoradiotherapy: Results of the Optimized Surgery and MRI-Based Multimodal Therapy Trial. J Am Coll Surg. 2020 Oct;231(4):413-425.e2. doi: 10.1016/j.jamcollsurg.2020.06.023. Epub 2020 Jul 19.
- Kreis ME, Ruppert R, Ptok H, Strassburg J, Brosi P, Lewin A, Schon MR, Sauer J, Junginger T, Merkel S, Hermanek P; OCUM study group. Use of Preoperative Magnetic Resonance Imaging to Select Patients with Rectal Cancer for Neoadjuvant Chemoradiation--Interim Analysis of the German OCUM Trial (NCT01325649). J Gastrointest Surg. 2016 Jan;20(1):25-32; discussion 32-3. doi: 10.1007/s11605-015-3011-0. Epub 2015 Nov 10.
- Kreis ME, Maurer CA, Ruppert R, Ptok H, Strassburg J, Junginger T, Merkel S, Hermanek P. [Lymph node dissection after primary surgery and neoadjuvant radiochemotherapy of rectal cancer. Interim analysis of a multicenter prospective observational study (OCUM)]. Chirurg. 2015 Dec;86(12):1132-7. doi: 10.1007/s00104-015-0062-4. German.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
March 29, 2011
First Posted (Estimate)
March 30, 2011
Study Record Updates
Last Update Posted (Estimate)
October 19, 2016
Last Update Submitted That Met QC Criteria
October 18, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ocumstudy 19.08.2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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