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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total mesorectal excision / long course radiochemotherapy | Procedure | long course 5-FU based radiochemotherapy before total mesorectal excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional recurrence rate | Five year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with carcinoma of the middle rectum with positive mrCRM (≤ 1 mm), with cT3 low rectal carcinoma, and with cT4 tumors
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Center Department of General and Abdomial Surgery | Mainz | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37335957 | Derived | Ruppert R, Junginger T, Kube R, Strassburg J, Lewin A, Baral J, Maurer CA, Sauer J, Lauscher J, Winde G, Thomasmeyer R, Stelzner S, Bambauer C, Scheunemann S, Faedrich A, Wollschlaeger D, Merkel S. Risk-Adapted Neoadjuvant Chemoradiotherapy in Rectal Cancer: Final Report of the OCUM Study. J Clin Oncol. 2023 Aug 20;41(24):4025-4034. doi: 10.1200/JCO.22.02166. Epub 2023 Jun 19. | |
| 32697965 |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| long course 5-FU bases radiochemotherapy | Radiation |
|
| Derived |
| 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. |
| 26556476 | Derived | 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. |
| 26223668 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |