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NCT Number: NCT07688135

Quicksilver II Pilot Study

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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Key information

Conditions

Stage II Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Stage III Rectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Accrual rate

    Time frame: 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

  1. Local recurrence

    Time frame: 2 years

    Recurrent disease anywhere inside the pelvis

  2. Distant recurrence

    Time frame: 2 years

    Recurrent disease outside the pelvis

  3. Survival

    Time frame: 2 years

    Survival events up to 6 months after the accrual period.

  4. Questionnaire: European Organization for Research and Treatment of Cancer - Quality of Life (QLQ-C30)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin D Kennedy, MD, PhD

CONTACT

[email protected]

416-586-4800 ext. 6872

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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