Clinical Trial

Quicksilver II Pilot Study

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Trial Details
NCT Number NCT07688135
Lead Sponsor Mount Sinai Hospital, Canada
Conditions Stage II Rectal Cancer, Stage III Rectal Cancer
Enrollment 18 participants
Start Date 2026-09
Primary Completion 2028-09 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-07