OCUM: Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma

• Sponsor: Johannes Gutenberg University Mainz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01325649
• Collaborator: (none)
• Enrollment: 1,051
• Location: 1
• Duration (Months): 91
• Patients Per Site Per Month: 11.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer Stage II; Rectal Cancer Stage III	Procedure: total mesorectal excision / long course radiochemotherapy; 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1051 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	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	Procedure: total mesorectal excision / long course radiochemotherapy; long course 5-FU based radiochemotherapy before total mesorectal excision; Radiation: long course 5-FU bases radiochemotherapy

Outcome Measures

Primary Outcome Measures

1. Locoregional recurrence rate [Five year]

Secondary Outcome Measures

1. Rate of involvement of circumferential resection margin (pCRM positive of resected specimens [postoperative]

   pCRM positive means a distance of the tumor from circumferential resection margin 1mm or less.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Medicine Center Department of General and Abdomial Surgery	Mainz		Germany	55131

Sponsors and Collaborators

• Johannes Gutenberg University Mainz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theo Junginger, MD, Johannes Gutenberg University Mainz
• ClinicalTrials.gov Identifier: NCT01325649
• Other Study ID Numbers: Ocumstudy 19.08.2009
• First Posted: Mar 30, 2011
• Last Update Posted: Oct 19, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Theo Junginger, MD, Johannes Gutenberg University Mainz: rectal cancer; MRI; selective preoperative radiochemotherapy; involvement of circumferential resection margin; locoregional recurrence rate
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Oct 19, 2016