Clinical trial NCT01325649: Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma
Official title: Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer Stage II
Rectal Cancer Stage III
Keywords: rectal cancer
MRI
selective preoperative radiochemotherapy
involvement of circumferential resection margin
locoregional recurrence rate
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 1051
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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 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

Primary outcomes:
measure: Locoregional recurrence rate
timeFrame: Five year
Secondary outcomes:
measure: Rate of involvement of circumferential resection margin (pCRM positive of resected specimens
timeFrame: postoperative
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medicine Center Department of General and Abdomial Surgery
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.