Quicksilver: a study to assess the safety of a new MRI approach to pre-operatively stage rectal cancer and guide treatment

ISRCTN ISRCTN05107772
DOI https://doi.org/10.1186/ISRCTN05107772
Secondary identifying numbers N/A
Submission date
03/07/2014
Registration date
23/07/2014
Last edited
12/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Erin Kennedy
Scientific

Mount Sinai Hospital
600 University Avenue
Toronto
M5G 1X5
Canada

Study information

Study designPhase II prospective cohort study
Primary study designInterventional
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet N/A
Scientific titleA Phase II prospective cohort study to assess the safety of a new MRI approach to pre-operatively stage rectal cancer and guide treatment
Study objectivesIt 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(s)Mount Sinai Hospital Research Ethics Board, 08/01/2014, ref: 13-0147A
Health condition(s) or problem(s) studiedRectal cancer
InterventionParticipants (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.

Added 12/09/2017: The MRI criteria for identifying "good prognosis tumors" has been amended and now studies are collecting additional 2-year outcomes on the participants. The 2-year outcomes collected include the following: (i) local recurrence, (ii) distant metastasis, (iii) disease free survival and (iv) overall survival.
Intervention typeOther
Primary outcome measureThe 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 measuresN/A
Overall study start date01/09/2014
Completion date01/06/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsA total of 75 patients from all participating centres across Canada
Total final enrolment82
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2014
Date of final enrolment01/09/2016

Locations

Countries of recruitment

  • Canada

Study participating centre

Mount Sinai Hospital
Toronto
M5G 1X5
Canada

Sponsor information

Mount Sinai Hospital (Canada)
Hospital/treatment centre

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

Website http://www.mountsinai.on.ca/
ROR logo "ROR" https://ror.org/05deks119

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2019 12/04/2019 Yes No

Editorial Notes

12/04/2019: Publication reference and total final enrolment added.
12/09/2017: Overall trial end date has been updated from 01/09/2016 to 01/06/2018. Interventions has been updated.