Quicksilver II Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada
About this trial
This pilot study is being done to answer the following question: Will patients with margin-clear Stage 2 or 3 rectal cancer who don't require a colostomy agree to be randomized to 'surgery only' or 'chemotherapy and then surgery'? Study participants will be randomized to receive either 12 weeks of chemotherapy before rectal cancer surgery or they will proceed directly to surgery. The researchers hypothesize that patients with margin-clear clinical Stage II or III rectal cancer can avoid neo-adjuvant (i.e., pre-operative) radiation and chemotherapy treatments and go directly to surgery. A positive pilot study will support funding requests for a related large efficacy trial; this larger trial, if positive, should lead to an important de-escalation innovation - avoiding use of neo-adjuvant chemoradiation and associated toxicity risks for patients with margin-clear Stage II or III rectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18+ years of age
able to provide written consent
MRI confirmed margin-clear Stage II or III rectal cancer
Disqualifiers
patients with tumour criteria that encourage neoadjuvant treatments regardless of margin-status (e.g. need for a permanent colostomy, T4 category, and one or more pelvic sidewall lymph nodes with a short axis diameter >7 mm).
Unable to provide consent (e.g., language barrier, cognitive issues).
Trial design
Design model
Single group
Treatments tested in this trial
Direct-to-surgery (i.e., no neoadjuvant chemotherapy)
Procedure/SurgeryPatients with pre-operative margin-clear Stage II or III rectal cancer and expected avoidance of a permanent colostomy will undergo computer-generated randomization in a 1:1 ratio to an experimental 'direct-to-surgery' arm or a control 'neoadjuvant chemotherapy and surgery' arm.
Control Group
Procedure/SurgeryThis is the current standard of care in which patients receive neoadjuvant chemotherapy and surgery.
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: SurgeryExperimental treatment 1 intervention
Group B: Chemotherapy & SurgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Accrual rate
This pilot study is being conducted to assess the feasibility for a larger trial. Feasibility will be measured by the accrual rate in this pilot trial (i.e., the percent of patients who consent to participate).
Time frame
2 yearsSecondary outcomes
1
Local recurrence
Recurrent disease anywhere inside the pelvis
Time frame
2 years2
Distant recurrence
Recurrent disease outside the pelvis
Time frame
2 years3
Survival
Survival events up to 6 months after the accrual period.
Time frame
2 years4
Questionnaire: European Organization for Research and Treatment of Cancer - Quality of Life (QLQ-C30)
The EORTC QLQ-C30 evaluates the health-related quality of life of cancer patients. Its 30 questions are converted to scores between 0 and 100. Higher scores on the functional and global health scales indicate better well-being, whereas higher scores on the symptom scales indicate greater severity
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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