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Recruiting NCT02292641

NCT02292641 Beyond TME Origins

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Clinical Trial Summary
NCT ID NCT02292641
Status Recruiting
Phase
Sponsor Imperial College London
Condition Neoplasms
Study Type INTERVENTIONAL
Enrollment 383 participants
Start Date 2014-09-25
Primary Completion 2026-12

Trial Parameters

Condition Neoplasms
Sponsor Imperial College London
Study Type INTERVENTIONAL
Phase N/A
Enrollment 383
Sex ALL
Min Age 16 Years
Max Age N/A
Start Date 2014-09-25
Completion 2026-12
Interventions
New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery

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Brief 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 Criteria

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

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