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Taking people in CanadaNo phase

Non-operative Care After Chemoradiotherapy for Low Rectal Cancer

Tests whether avoiding surgery is safe in adults with low rectal cancer that responds fully.

Key facts

Who runs it
Mount Sinai Hospital, Canada
Where
Toronto, CanadaSee the site
Trial code
Registry title
Non-operative Management for Locally Advanced Rectal Cancer
Status
Recruiting
People taking part
90 people, planned
Started
16 Mar 2018
Expected to end
Dec 2028
Type of study
Interventional
Treatments tested
  • Non-operative management
Record updated
23 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with low rectal cancer who finished chemoradiotherapy and show a complete clinical response. It tests watching closely instead of surgery.

Age
18 years or older
Sex
All sexes can join
Disease stage
Stage II or Stage III rectal cancer (T3-T4N0, AnyTN1-2) treated with chemoradiotherapy; surgery to remove the rectum (APR) was planned or likely; all signs of complete clinical response present 8 to 10 weeks after chemoradiotherapy.
Earlier treatment
Must have finished standard chemoradiotherapy: 50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine.

Main reasons for not taking part

  • Cannot have an MRI scan
  • Cancer that has spread (metastatic disease)
  • Pregnancy
  • Inflammatory bowel disease
  • More than one primary colorectal cancer, or another cancer within 5 years of treatment for this rectal cancer

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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
  • Provides written consent

Who cannot take part

  • Unfit for surgery
  • Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)
  • Inflammatory bowel disease
  • More than one primary colorectal cancer
  • Other malignancy within 5 years of treatment for current rectal cancer
  • Unable to undergo MRI
  • Pregnancy

Where in Canada

  • Sinai Health SystemToronto, CanadaContact: Erin KennedyTaking people

About the trial

What the trial wants to find out

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%.

The group in the trial

  • non-operative managementTreatment being tested

    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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
Plain-language title
Non-operative Care After Chemoradiotherapy for Low Rectal CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 June 2026