Non-operative management for Rectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rectal CancerNon-operative management - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will determine if it is safe to forgo surgery after chemoradiotherapy for low rectal cancer if the cancer responds well to the treatment.

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 2 years

2 years
Colostomy-free survival
Rate of disease-free survival
Rate of local re-growth
Rate of macroscopically positive resection margin
Rate of overall survival
6, 12, 24 months
Bowel Function
Quality of Life

Trial Safety

Trial Design

1 Treatment Group

non-operative management
1 of 1

Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: Non-operative management · No Placebo Group · N/A

non-operative management
Procedure
Experimental Group · 1 Intervention: Non-operative management · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
183 Previous Clinical Trials
64,024 Total Patients Enrolled
Erin KennedyPrincipal InvestigatorSinai Health System
1 Previous Clinical Trials
670 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient received CRT as standard of care and completed 50 Gy with 5-FU or capecitabine.
The planned or probable APR is the estimated annual percentage rate that a loan will have
8 to 10 weeks following CRT all the criteria for complete clinical response are met.
You must be at least 18 years old.\n
The text provides written consent for something.