Clinical trial NCT02292641: Beyond TME Origins
Official title: Investigating the Origins of Pelvic Recurrence in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Adenocarcinoma
Carcinoma
Keywords: Lower Gastrointestinal Tract
Rectum
Diagnostic Imaging
Magnetic Resonance Imaging
Pelvic Exenteration
Neoplasms
Adenocarcinoma
Carcinoma
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Pelican Cancer Foundation
First posted: 2014-11-17
Enrollment: 383
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: A prospective and retrospective cohort study to improve surgical and treatment planning using an imaging assessment proforma of advanced and recurrent colorectal cancers. This involves the implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning.

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

Primary outcomes:
measure: To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system.
timeFrame: 3 years
Secondary outcomes:
measure: To compare baseline prognostic features against type of recurrence
timeFrame: 3 and 5 years
measure: To compare the MRI type of recurrence against clinical outcomes
timeFrame: 1, 3 and 5 years
measure: To compare the MRI compartment(s) distribution of recurrence against clinical outcomes
timeFrame: 1, 3 and 5 years
measure: To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life
timeFrame: 1, 2, 3 and 5 years
measure: To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence
timeFrame: Up to 2 years
measure: To measure radiology inter-observer agreement for types of recurrence classification
timeFrame: 5 years
measure: To investigate health economic costs of patients with pelvic recurrence against type
timeFrame: Up to 3 years
measure: To map original radiotherapy volumes (including integrated boosts) against types of recurrence
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
state: London
city: Oxford
country: United Kingdom
facility: Churchill Hospital
state: Oxfordshire
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
Study officials:
affiliation: Imperial College London
name: Gina Dr Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: