RecruitingNot ApplicableNCT02292641

Beyond TME Origins

Investigating the Origins of Pelvic Recurrence in Colorectal Cancer

Sponsor

Imperial College London

Enrollment

383 participants

Start Date

Sep 25, 2014

Study Type

INTERVENTIONAL

Conditions

Carcinoma Neoplasms Adenocarcinoma

Summary

All patients with recurrent colorectal cancer in the pelvis are eligible. The original primary tumour staging scans and resected surgical specimen needs to be available. Patients' recurrence will be staged using our proposed MRI classification. We will be assessing the original primary staging scans and histopathology to learn about risk factors for recurrence. We will record treatment for the recurrence, and patients will be followed up for three years.

Eligibility

Min Age: 16 Years

Inclusion Criteria6

Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice
Has a confirmed diagnosis of recurrent pelvic colorectal cancer
Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum
Are able to undergo high resolution MRI for staging prior to treatment decisions
Have provided written informed consent to participate in the study
Be aged 16 years or over

Exclusion Criteria3

Have irresectable extra-pelvic metastatic disease
Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable
Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable

Interventions

PROCEDURENew Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery

Currently there are no validated criteria or guidelines for judging whether advanced primary or recurrent colorectal cancer can be successfully removed and for selecting which patients should undergo this form of more radical surgery as is exenterative surgery. We are proposing that by validating the detailed evaluation of imaging of the tumour distribution within the pelvis using a new radiological staging classification, this will enable clear selection criteria to be established and will improve surgical planning.