Clinical trial · Observational
Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma
Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
NCT01325649CI-TRIAL-00024355OCUMcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer Stage II | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Cancer Stage III | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| long course 5-FU bases radiochemotherapy | Radiation | — | UNRESOLVED |
| total mesorectal excision / long course radiochemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- advanced rectal cancer
- description
- 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
- interventionNames
- Procedure: total mesorectal excision / long course radiochemotherapy
- Radiation: long course 5-FU bases radiochemotherapy
Primary outcomes (1)
- measure
- Locoregional recurrence rate
- timeFrame
- Five year
Secondary outcomes (1)
- measure
- Rate of involvement of circumferential resection margin (pCRM positive of resected specimens
- timeFrame
- postoperative
- description
- pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDRuppert 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. PMID 37335957
- DERIVEDRuppert 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. PMID 32697965
- DERIVEDKreis 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. PMID 26556476
- DERIVEDKreis 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. PMID 26223668