Rectal Cancer Alliance of Canada The webinar will begin shortly All participant lines will be muted during the presentation. Following the presentation, all participant lines will be unmuted for discussion and question period identify “good prognosis” Stage II and Stage III rectal cancer patients eligible for primary surgery (QuickSilver)
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Rectal Cancer Alliance of Canada The webinar will begin shortly All participant lines will be muted during the presentation. Following the presentation,
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Rectal Cancer Alliance of Canada
The webinar will begin shortly
All participant lines will be muted during the presentation.
Following the presentation, all participant lines will be unmuted for discussion and question period
Phase II study using MRI to identify “good prognosis” Stage II and Stage III
rectal cancer patients eligible for primary surgery
(QuickSilver)
Webinar Overview
QuickSilver Study Protocol• Discussion and Questions
Radiology Protocol
• Discussion and Questions
Pathology Protocol
• Discussion and Questions
• Wrap Up and Next Steps
QuickSilver Study and Site Leads
Study Leads
Radiology Laurent Milot (Toronto)
Mark Fruitman (Toronto)
Blair MacDonald (Ottawa)
Surgery Carl Brown (Vancouver)
Lara Williams (Halifax)
Pathology Richard Kirsch (Toronto)
David Driman (London)
Radiation Oncology Charles Cho (Toronto)
Raimond Wong (Hamilton)
Medical Oncology Monika Krzyzanowska (Toronto)
Ron Burkes (Toronto)
Principal Investigators Erin Kennedy, Nancy Baxter, Marko Simunovic, Robin McLeod
Introduction
PreCRT is recommended for Stage II and Stage III rectal cancer to decrease the risk of local recurrence
While preCRT reduces the risk of LR, it does not improve survival and leads to poorer bowel and sexual function than surgery alone
New approaches to improve selection and limit preCRT to Stage II and Stage III rectal cancer patients who are most likely to benefit from preCRT are important
Introduction
2 non-randomized, prospective studies have used MRI to identify “good prognosis” rectal tumours eligible for primary surgery
Patients with MRI predicted “good prognosis” tumours underwent primary surgery with favourable outcomes UK: Positive CRM 3.3% (4/122)
LR @ 2 years 3.3% (4/122)
German: Positive CRM 6.0% (11/181)Taylor, Annals of Surgery, 2011Strassburg. Annals of Surgical Oncology, 2011
MRI Criteria for “Good Prognosis” Tumours
UK (Mercury) German
Predicted CRM CRM > 1 mm CRM > 1 mm
T-category and
Extramural depth of invasion (EMD)
T1, T2 or T3 with < 5 mm EMD
T1, T2 or any T3
N-category N0, N1, N2 N0, N1, N2
Extramural vascular invasion (EMVI) Negative Not assessed
Tumour Height Any tumour 0-15 cm from anal verge**(Low rectal tumours < 5 cm from the anal verge with no invasion of the intersphincteric plane)
Any tumour > 6 cm and < 12 cm from the anal verge
N-category and Local Recurrence
May not be as important as previous RCTs suggest• Pre-operative staging by DRE; no routine imaging
• Quality of surgery
Study Local Staging
Dutch DRE – fixed tumours excluded
MRC CRO7 DRE- tumours fixed to pelvis excludedIf DRE inconclusive; EUA supplemented when appropriate by pelvic CT, MRI or TRUS
Study TME Complete
Dutch 57% (102/180)
MRC CR07 52% (604/1156)
QuickSilver Objectives
To conduct a pan Canadian Phase II study to assess the safety of using MRI criteria to identify “good prognosis” Stage II and Stage III rectal cancer patients eligible for primary surgery
QuickSilver Consensus Meeting
One-day investigator’s meeting on June 2013 attended by 35 physicians from across Canada
Documentation of use of the Quirke method* (i.e. fixation of the unopened specimen followed by cross sectional slicing) Quality (i.e. completeness) of the TME (state various elements)
Documentation of the number of tumour blocks with deepest tumour invasion (at least 3 required) to include CRM where applicable *
Documentation that photographs of the specimen taken*
Microscopic Assessment ItemsSite and relationship of tumour to the anterior peritoneal reflection*
Microscopic tumour extension (T-category)
Extramural depth of invasion* (T3 tumours only) (i.e., deepest invasion of tumour into the mesorectal fat)
Lymph node status (N-category)
Closest distance of the distal margin in mm (in all cases, even when not the closest margin)*
Closest distance of CRM in mm (in all cases, even when not the closest margin)*
Structure closest to the CRM (tumour, tumour nodule, lymph node, venous invasion)*
Extramural venous invasion (elastin stain: to be performed on 3 blocks with deepest invasion)*
* Indicates item is not on CAP checklist but is required for this study
QuickSilver Pathologic Assessment
If any uncertainty about pathology criteria, the reporting pathologist will review with the Pathology Site Lead to achieve consensus
If consensus not achieved, central review by Lead Pathologists for study (Richard Kirsch, David Driman)
Pathology reports FAXed to central study office
Pathology Site Lead will be contacted in case of any missing data
NEXT STEPS
Thank you to everyone!
Welcome any further comments about the study up until Sept 29, 2014
Site Leads to review and finalize website and information booklet by Oct 1, 2014
Informed consent in-service with centres as REB is approved