Non-operative Management for Locally Advanced Rectal Cancer
ConditionRectal Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada
About this trial
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%.
Eligibility criteria
Qualifiers
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
Disqualifiers
Unable to undergo MRI
Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)
Pregnancy
Inflammatory bowel disease
Trial design
Treatments tested in this trial
- Non-operative management
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov