Condition category
Cancer
Date applied
03/07/2014
Date assigned
23/07/2014
Last edited
23/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
All patients diagnosed with rectal cancer have an MRI to determine whether the rectal cancer is early or advanced. Patients with early cancer proceed directly to surgery and based on tests done on the rectal cancer after surgery may require chemotherapy and/or radiation. Patients with advanced rectal cancer have chemotherapy and radiation before surgery and chemotherapy after surgery. The advantage of having chemotherapy and radiation before surgery is that it decreases the risk of the rectal cancer coming back. However, the disadvantage of having chemotherapy and radiation before surgery is that it does not improve overall survival (i.e. chance of cure) and leads to slightly poorer bowel and sexual function than when surgery is performed alone. Therefore, the results of the MRI are very important because they determine whether the rectal cancer is early or advanced and whether or not chemotherapy and radiation will be required before surgery.
Currently, the standard criteria used on MRI to determine whether the rectal cancer is early or locally advanced are depth of tumour invasion into the bowel wall (T-category) and involvement of lymph nodes (N-category). Recently, two studies from Europe have used new MRI criteria using the predicted resection margin (rim of normal tissue surrounding the tumour) to determine whether the rectal cancer is early or locally advanced. These studies showed that when using this new MRI criteria, more rectal cancers were classified as early and, therefore, fewer patients required chemotherapy and radiation before surgery. These studies showed that even though fewer patients received chemotherapy and radiation before surgery, the risk of the rectal cancer coming back was low. Since these studies were done in different countries, the purpose of this study is to assess whether the new MRI criteria is safe to use in Canada.

Who can participate?
Patients aged 18 years or older with rectal cancer.

What does the study involve?
Participants will receive the exact same tests and surgery that they would receive if they were not participating in this study. However, instead of using the current selection criteria to make a treatment recommendation about having chemotherapy and radiation before surgery, a less strict selection criteria will be used to decide whether or not to recommend chemotherapy and radiation. This means that by participating in the study, participants will be less likely to receive chemotherapy and radiation than if they were not participating in the study. The surgical procedure they receive will be the same regardless of whether or not they participate in this study, as will their care following surgery. The portion of the rectum (including the tumour) that has been removed will be examined in the usual way by the pathologist.

What are the possible benefits and risks of participating?
The potential benefit of not undergoing chemotherapy and radiation before surgery is that the length of treatment will be about 2-3 months shorter and participants will have better bowel and sexual function with surgery alone than if they have chemotherapy and radiation before surgery. Although two studies have shown that using the new MRI criteria is safe and has the same local recurrence rate as standard MRI criteria (which is around 7.5%), we are not 100% certain of this. Therefore, while we do not think that the local recurrence rate will be more than 7.5% using the new MRI criteria, there is a chance that the local recurrence rate could be as high as 15%, which is two times higher than our standard approach.

Where is the study run from?
Fifteen hospitals from across Canada will be participating in this study.

When is the study starting and how long is it expected to run for?
The study will start in September 2014 and end in September 2016.

Who is funding the study?
Mount Sinai Hospital (Canada).

Who is the main contact?
Dr Erin Kennedy

Trial website

Contact information

Type

Scientific

Primary contact

Dr Erin Kennedy

ORCID ID

Contact details

Mount Sinai Hospital
600 University Avenue
Toronto
M5G 1X5
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A Phase II prospective cohort study to assess the safety of a new MRI approach to pre-operatively stage rectal cancer and guide treatment

Acronym

Study hypothesis

It is expected that the results of this study will show that this new approach to the selection of rectal cancer patients for pre-operative chemoradiotherapy using MRI to predict the circumferential resection margin will be safe.

Ethics approval

Mount Sinai Hospital Research Ethics Board, 08/01/2014, 13-0147A

Study design

Phase II prospective cohort study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

N/A

Condition

Rectal cancer

Intervention

Participants (i.e., rectal cancer patients) in this study will receive the exact same tests and surgery that they would receive if they were not participating in this study. However, instead of using the current or more strict selection criteria to make a treatment recommendation about pre-operative chemoradiotherapy (preCRT), a more refined or less strict selection criteria will be used to decide whether or not to recommend preCRT. This means that by participating in the study, participants will be less likely to receive preCRT than if they were not participating in the study. The surgical procedure they receive will be the same regardless of whether or not they participate in this study, as will their care following surgery. The portion of the rectum (including the tumour) that has been removed will be examined in the usual way by the pathologist.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

The primary outcome for the study will be the safety of this new MRI approach in terms of positive circumferential resection margin (CRM) in the pathological specimen. The positive CRM rate is a well-established and accepted surrogate measure of local recurrence and the new MRI criteria will be considered safe if a positive CRM rate of less than 5% is achieved.

Secondary outcome measures

N/A

Overall trial start date

01/09/2014

Overall trial end date

01/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of rectal cancer (0-15 cm) from the anal verge on endoscopy and/or proximal extent of tumour at or below the sacral promontory on CT or MRI
2. 18 years or older
3. Able to provide written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 75 patients from all participating centres across Canada

Participant exclusion criteria

1. Planned abdomino-perineal resection (APR) based on pre-treatment assessment
2. Planned local excision based on pre-treatment assessment
3. Suspicious extramesorectal lymph nodes on MRI
4. Unable to undergo MRI due to claustrophobia, metal fragments, implanted metal devices or contrast allergy
5. Metastatic disease (including extramesorectal lymph nodes, carcinomatosis, liver, lung)
6. Pregnancy
7. Inflammatory bowel disease
8. Previous pelvic radiation
9. More than one primary tumour

Recruitment start date

01/09/2014

Recruitment end date

01/09/2016

Locations

Countries of recruitment

Canada

Trial participating centre

Mount Sinai Hospital
Toronto
M5G 1X5
Canada

Sponsor information

Organisation

Mount Sinai Hospital (Canada)

Sponsor details

Toronto General Hospital
NCSB LC-412
585 University Avenue
Toronto
M5G N2N
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.mountsinai.on.ca/

Funders

Funder type

Hospital/treatment centre

Funder name

Mount Sinai Hospital (Canada), University Health Network Academic Medical Organization Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes