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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

Must not have

More than one primary colorectal cancer

Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had more than one primary colorectal cancer.

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My cancer has spread beyond its original location.

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I am not a candidate for surgery due to my health condition.

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I have not had any other cancer within 5 years besides my current rectal cancer.

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I have inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of local re-growth

Rate of macroscopically positive resection margin

Secondary study objectives

Bowel Function

Colostomy-free survival

Quality of Life

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met