Clinical Trials in Norway / NCT02292641
Recruiting Not applicable

Beyond TME Origins

NCT02292641 · tracked via the Priya Life Science Norway tracker
Phase
Not applicable
Started
2014-09-25
Last updated
2024-10-17

Condition(s) studied

NeoplasmsAdenocarcinomaCarcinoma

Investigational drug(s) / intervention(s)

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

New 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.

Study 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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Had a primary colorectal adenocarcinoma proven by biopsy taken as part of routine clinical practice 2. Has a confirmed diagnosis of recurrent pelvic colorectal cancer 3. Has previously completed surgical treatment of primary adenocarcinoma of the colon, sigmoid colon or rectum 4. Are able to undergo high resolution MRI for staging prior to treatment decisions 5. Have provided written informed consent to participate in the study 6. Be aged 16 years or over Exclusion Criteria: 1. Have irresectable extra-pelvic metastatic disease 2. Original baseline staging and preoperative restaging scans (MR for rectal and sigmoid cancers and/or CT for colon and sigmoid cancers) are unavailable 3. Original preoperative, surgical and adjuvant treatment has not been documented or is unavailable

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway Recruiting
St Mark's Hospital Harrow London Recruiting
Churchill Hospital Oxford Oxfordshire Recruiting
Royal Marsden Hospital NHS Foundation Trust Sutton United Kingdom Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02292641 on ClinicalTrials.gov ↗ ← All trials in Norway