Quicksilver II Pilot Study

NCT07688135 — Not applicable, Not yet recruiting, 18 participants, Mount Sinai Hospital, Canada

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Quicksilver II Non-inferiority Randomized Controlled Trial: Direct-to-surgery or Neoadjuvant Chemotherapy and Surgery in Margin-clear Stage II or III Rectal Cancer

Registry	NCT07688135
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	18 (Estimated)
Sponsor	Mount Sinai Hospital, Canada (Other)
Conditions	Stage II Rectal Cancer, Stage III Rectal Cancer
Interventions	Direct-to-surgery (i.e., no neoadjuvant chemotherapy), Control Group (Procedure)
Dates	start 2026-09-01 (estimated), primary completion 2028-09-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-07-07, last updated 2026-07-07

-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.

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+Detailed description

Before patients with rectal cancer go for surgery, tests determine tumour stage and if there are cancer cells near the edge of the rectum - if there are no cancer cells near the edge the tumour is called 'margin-clear'. Surgeons operate just outside the 'margin' to best remove all cancer cells. In Canada, patients with stage 2 or 3 cancer are almost always given radiation and chemotherapy before surgery to lower the risk the cancer will return. However, these treatments can cause life-long side effects like poor bowel function or nerve damage in the hands. A small study of patients with margin-clear stage 2 and 3 rectal cancer showed that radiation and chemotherapy is likely not needed before surgery. However, researchers would like to test these findings in a larger trial called "Quicksilver II". Before applying for Quicksilver II funding, the researchers have to show the trial steps are possible. This will be accomplished through a feasibility/pilot trial at several high-volume rectal cancer centres. Patients with margin-clear stage 2 or 3 rectal cancer will be randomized to 'surgery' or 'chemotherapy and surgery'. If the pilot study works and if Quicksilver II is positive, it may change the way patients with margin-clear tumours are treated around the world.

+Arms and interventions

Arm	Type	Interventions	Description
Surgery	Experimental	Procedure: Direct-to-surgery (i.e., no neoadjuvant chemotherapy)
Chemotherapy & Surgery	Active comparator	Procedure: Control Group	The current standard of care, which is 'neoadjuvant chemotherapy and surgery'

Direct-to-surgery (i.e., no neoadjuvant chemotherapy) (Procedure): Patients 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): This is the current standard of care in which patients receive neoadjuvant chemotherapy and surgery.

+Outcome measures

Primary outcomes

Accrual rate [2 years]: 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).

Secondary outcomes

Local recurrence [2 years]: Recurrent disease anywhere inside the pelvis
Distant recurrence [2 years]: Recurrent disease outside the pelvis
Survival [2 years]: Survival events up to 6 months after the accrual period.
Questionnaire: European Organization for Research and Treatment of Cancer - Quality of Life (QLQ-C30) [2 years]: 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* 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).