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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Non-operative management
Procedure/SurgeryPatients who are eligible and provide informed consent to participate in the trial will undergo non-operative management (i.e., active surveillance for 24 months) according to the schedule outlined in the study protocol.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: non-operative managementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of local re-growth
The safety of non-operative management will be evaluated by assessing the rate of local re-growth in the study population. This approach will be considered safe if the local re-growth rate is equal to or less than 30%.
Time frame
2 years2
Rate of macroscopically positive resection margin
The safety of non-operative management will be evaluated by assessing the rate of macroscopically positive resection margin following surgery in the study population. This approach will be considered safe if the rate is 0%.
Time frame
2 yearsSecondary outcomes
1
Rate of overall survival
Rate of overall survival in the study population assessed 2 years after completion of CRT
Time frame
2 years2
Rate of disease-free survival
Rate of disease-free survival in the study population assessed 2 years after completion of CRT
Time frame
2 years3
Colostomy-free survival
Rate of colostomy-free survival in the study population assessed 2 years after completion of CRT
Time frame
2 years4
Quality of Life
Quality of life will be measured using the EORTC C30 questionnaire and will be assessed at 6, 12 and 24 months.
Time frame
6, 12, 24 monthsSponsors and contacts
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Source ClinicalTrials.gov