Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pelican Cancer Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with pelvic recurrence from primary colorectal cancer | Other | Implementation of imaging assessment proformas describing anatomic pelvic compartments and aetiology of disease recurrence for treatment planning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To change R0 resection rates for locally recurrent rectal cancers with the use of the proposed staging system. | An increase of 20% in R0 resection (from 55% to 75%) for locally recurrent rectal cancers with the use of the proposed staging system | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To compare baseline prognostic features against type of recurrence | Correlation of baseline and post treatment prognostic factors on imaging and pathology against type of recurrence. | 3 and 5 years |
| To compare the MRI type of recurrence against clinical outcomes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Martin | Contact | +44 (0) 7749 655 817 | c.martin1@imperial.ac.uk | |
| Syvella Ellis | Contact | +44 (0) 7732 315 234 | giclinicaltrials@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gina Dr Brown, MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | N-0424 | Norway |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Proportion of patients with survival >12mths according to type of recurrence as described on MRI |
| 1, 3 and 5 years |
| To compare the MRI compartment(s) distribution of recurrence against clinical outcomes | Proportion of patients with survival >12mths according to compartment(s) of recurrence as described on MRI | 1, 3 and 5 years |
| To investigate the effect of surgical and non-surgical treatments for recurrence on Quality of Life | Quality of life assessed using EORTC QLQ-C30 | 1, 2, 3 and 5 years |
| To compare radiology and histopathology compartments in patients undergoing beyond TME surgery for recurrence | The number of compartments predicted as involved on MRI against the number of compartments reported on the corresponding pathology specimens | Up to 2 years |
| To measure radiology inter-observer agreement for types of recurrence classification | Kappa agreement between paired radiologists for type of recurrence | 5 years |
| To investigate health economic costs of patients with pelvic recurrence against type | Healthcare costs using NHS Reference Costs combined with health resource utilization and QoL data | Up to 3 years |
| To map original radiotherapy volumes (including integrated boosts) against types of recurrence | Correlation of dose, type and distribution of radiotherapy against anatomic sites and aetiology of recurrence as seen on MRI | Up to 2 years |
| St Mark's Hospital | Recruiting | Harrow | London | United Kingdom |
|
| Churchill Hospital | Recruiting | Oxford | Oxfordshire | United Kingdom |
|
| Royal Marsden Hospital NHS Foundation Trust | Recruiting | Sutton | SM2 5PT | United Kingdom |
|