Optimal Surgery and MRI Based Radiochemotherapy in Rectal Carcinoma (OCUM)

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Rectal Cancer Stage III; Rectal Cancer Stage II

Treatments: Procedure: total mesorectal excision / long course radiochemotherapy; Radiation: long course 5-FU bases radiochemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT01325649

Ocumstudy 19.08.2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,051 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,051 participants in 1 patient group

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

Treatment:

Radiation: long course 5-FU bases radiochemotherapy

Procedure: total mesorectal excision / long course radiochemotherapy