Stage II Rectal CancerNCT07688135
Quicksilver II Pilot Study
A study testing Direct-to-surgery (i.e., no neoadjuvant chemotherapy) in people with Stage II Rectal Cancer and Stage III Rectal Cancer, run by Mount Sinai Hospital, Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Rectal Cancer, Stage III Rectal Cancer
- What is being tested?
- Direct-to-surgery (i.e., no neoadjuvant chemotherapy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- able to provide written consent
- MRI confirmed margin-clear Stage II or III rectal cancer
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Stage II Rectal Cancer, Stage III Rectal Cancer
- Being tested
- Direct-to-surgery (i.e., no neoadjuvant chemotherapy), Control Group
- Keywords
- rectal cancer, prospective randomized controlled trial, change patient care, direct-to-surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-to-surgery (i.e., no neoadjuvant chemotherapy)Procedure or surgery
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 GroupProcedure or surgery
This is the current standard of care in which patients receive neoadjuvant chemotherapy and surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Not described Receives: Procedure: Direct-to-surgery (i.e., no neoadjuvant chemotherapy) |
| Chemotherapy & Surgery | Active comparator | The current standard of care, which is 'neoadjuvant chemotherapy and surgery' Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate
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).
Measured: 2 years
Secondary outcomes (4)
Local recurrence
Recurrent disease anywhere inside the pelvis
Measured: 2 years
Distant recurrence
Recurrent disease outside the pelvis
Measured: 2 years
Survival
Survival events up to 6 months after the accrual period.
Measured: 2 years
Questionnaire: European Organization for Research and Treatment of Cancer - Quality of Life (QLQ-C30)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Kennedy, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688135
- Sponsor's protocol ID
- SUMO (Round 12 )
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07688135
- Acronym / sponsor ID
- SUMO (Round 12 )
- Conditions
- Stage II Rectal Cancer, Stage III Rectal Cancer
- Keywords
- rectal cancer, prospective randomized controlled trial, change patient care, direct-to-surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Direct-to-surgery (i.e., no neoadjuvant chemotherapy) |
| Chemotherapy & Surgery | Active comparator | Procedure: Control GroupThe current standard of care, which is 'neoadjuvant chemotherapy and surgery' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+ years of age
- able to provide written consent
- MRI confirmed margin-clear Stage II or III rectal cancer
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct-to-surgery (i.e., no neoadjuvant chemotherapy)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. | Procedure or surgery | Surgery |
| Control GroupThis is the current standard of care in which patients receive neoadjuvant chemotherapy and surgery. | Procedure or surgery | Chemotherapy & Surgery |
Primary outcome
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).
4 secondary outcomes
Local recurrence
Time frame: 2 years
Distant recurrence
Time frame: 2 years
Survival
Time frame: 2 years
Questionnaire: European Organization for Research and Treatment of Cancer - Quality of Life (QLQ-C30)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Direct-to-surgery (i.e., no neoadjuvant chemotherapy) in people with Stage II Rectal Cancer and Stage III Rectal Cancer, run by Mount Sinai Hospital, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin D Kennedy, MD, PhD (416-586-4800 ext. 6872, erin.kennedy@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.