NCT07688135Not yet recruiting
Quicksilver II Pilot Study
Quicksilver II Non-inferiority Randomized Controlled Trial: Direct-to-surgery or Neoadjuvant Chemotherapy and Surgery in Margin-clear Stage II or III Rectal Cancer
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Mount Sinai Hospital, Canada
- Diseases
- Colorectal cancer
- NCT number
- NCT07688135
What you commit to
- Study type: Interventional
- Planned participants: 18
- From Sept 2026 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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).
Who the study is looking for
- 18+ years of age
- able to provide written consent
- MRI confirmed margin-clear Stage II or III rectal cancer
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.