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Non-operative Management for Rectal Cancer (NOM Trial)

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Recruiting
Led By Erin Kennedy
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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]
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

NOM Trial 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.

Who is the study for?
This trial is for adults over 18 with low rectal cancer who've finished chemoradiotherapy and show no signs of the cancer remaining. It's not for those pregnant, with other cancers in the last 5 years, inflammatory bowel disease, unable to have an MRI, metastatic disease, unfit for surgery or multiple colorectal cancers.Check my eligibility
What is being tested?
The study tests if patients with a complete response to chemoradiotherapy can safely skip surgery. Over five years, it'll check how often the cancer comes back and if any subsequent surgeries due to regrowth result in clear margins around the tumor.See study design
What are the potential side effects?
Since this trial involves non-operative management after standard treatment rather than additional drugs or procedures, side effects are related to potential cancer regrowth rather than typical medication or surgical complications.

NOM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed standard chemoradiotherapy for stage II or III cancer.
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I am 18 years old or older.

NOM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of local re-growth
Rate of macroscopically positive resection margin
Secondary outcome measures
Bowel Function
Colostomy-free survival
Quality of Life
+2 more

NOM Trial Design

1Treatment groups
Experimental Treatment
Group I: non-operative managementExperimental Treatment1 Intervention
Patients with low rectal cancer who have achieved a complete clinical response following chemoradiotherapy will undergo active follow-up with regular clinical visits, physical exam, endoscopy and imaging assessments at regular intervals for 2 years to assess for tumour re-growth or spread to the liver and lungs

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,518 Total Patients Enrolled
Erin KennedyPrincipal InvestigatorSinai Health System
1 Previous Clinical Trials
670 Total Patients Enrolled

Media Library

Rectal Cancer Clinical Trial 2023: Non-operative management Highlights & Side Effects. Trial Name: NCT03179540 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently seeking participants?

"Data on clinicaltrials.gov reveals that this experiment, which was initially posted in March of 2018, is currently seeking volunteers. Last updated at the end of August 2022, it continues to seek appropriate candidates for the trial."

Answered by AI

What is the uppermost threshold of individuals involved in this research?

"Affirmative. The clinicaltrials.gov website reveals that the trial, initially posted on March 16th 2018, is still recruiting patients with 90 participants sought from a single medical centre."

Answered by AI

What is the end-objective of this experiment?

"The primary aim of this research endeavour, lasting two years in total, is to measure the Rate of macroscopically positive resection margin. Moreover, secondary objectives include the evaluation of Rate of overall survival (2 years post CRT), Colostomy-free survival rate (2 years after completion of CRT) and Rate of disease-free survival (also 2 years post CRT)."

Answered by AI

Who else is applying?

What site did they apply to?
Sinai Health System
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Non-operative Management for Locally Advanced Rectal Cancer
2018. "Non-operative Management for Locally Advanced Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03179540.
All > Rectal Cancer
~13 spots leftby Apr 2025
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