Recruiting

Observational Study

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03179540

Conditions

Rectal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-operative management

Study Details

Brief summary:

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%.

Conditions

Rectal Neoplasms

Study ID

NCT03179540

Start date

Mar 16, 2018

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: non-operative management

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

Interventions

Non-operative management

Patients 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.

Primary outcome measure

  • Rate of local re-growth [ Time Frame: 2 years ]
  • Rate of macroscopically positive resection margin [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Erin Kennedy

416-586-4800erin.kennedy@sinaihealthsystem.ca

Selina Schmocker

416-586-4800selina.schmocker@sinaihealthsystem.ca

Locations

Sinai Health System

Recruiting

Toronto, Ontario, Canada, M5T 3L9

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Low Rectal Cancer
  • Complete Clinical Response
  • Non-operative Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-06-23.