Quicksilver II Pilot Study

Starting soon · Not applicable

Conditions studied: Stage II Rectal Cancer, Stage III Rectal Cancer

In brief

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.

Key facts

Study ID

NCT07688135

Run by

Mount Sinai Hospital, Canada

People needed

18

Starts

2026-09-01

Expected to finish

2028-12-01

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18+ years of age
• able to provide written consent
• MRI confirmed margin-clear Stage II or III rectal cancer

You may not qualify if…

• 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).

Full record on ClinicalTrials.gov

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