Non-operative Management for Locally Advanced Rectal Cancer
Recruiting · NCT03179540 · Interventional (participants receive a specific treatment) · Lead sponsor: Mount Sinai Hospital, Canada
View the official record on ClinicalTrials.gov →Interventions studied
Non-operative management
What this trial is about
This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Completed chemoradiotherapy (CRT) as standard of care \[Stage II and Stage III (T3-T4N0, AnyTN1-2)\]; \[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\]
- Planned or probable APR
- ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT
- 18 years or older
- Provides written consent
Exclusion criteria
- Unable to undergo MRI
- Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)
- Pregnancy
- Inflammatory bowel disease
- More than one primary colorectal cancer
- Other malignancy within 5 years of treatment for current rectal cancer
- Unfit for surgery
Where it is running
1 location listed.
- Sinai Health System - Toronto, Ontario, Canada