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Completed

NCT Number: NCT01325649

Optimal Surgery and MRI Based Radiochemotherapy in 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.

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Key information

Conditions

Rectal Cancer Stage II Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Stage III Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Center Department of General and Abdomial Surgery

Mainz, 55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total mesorectal excision / long course radiochemotherapy

Procedure

long course 5-FU based radiochemotherapy before total mesorectal excision

long course 5-FU bases radiochemotherapy

Radiation

Primary outcomes

  1. Locoregional recurrence rate

    Time frame: Five year

Secondary outcomes

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

    Time frame: postoperative

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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Optimal Surgery With Total Mesorectal Excision and MRI Based Multimodal Therapy of Rectal Carcinoma

Acronym: OCUM

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Mar 30, 2011
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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