Stage III Rectal Cancer, Stage II Rectal Cancer
Conditions
Keywords
rectal cancer, prospective randomized controlled trial, change patient care, direct-to-surgery
Brief 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.
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.
Interventions
PROCEDUREDirect-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.
PROCEDUREControl Group
This is the current standard of care in which patients receive neoadjuvant chemotherapy and surgery.
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
CONTACTErin D Kennedy, MD, PhD
Outcome results
None listed