Non-operative Management for Locally Advanced Rectal Cancer (NOM)

November 18, 2024 updated by: Mount Sinai Hospital, Canada

Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer

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%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: The standard treatment for low rectal cancer (LRC) involving the anal sphincter involves combined, pre-operative chemotherapy and radiotherapy (CRT) followed by surgery. Surgery involves removal of the rectum and anus and creation of a permanent colostomy and has significant long term effects on bowel and sexual function and body image. Because of the high morbidity of surgery, there has been increasing interest in non-operative management (NOM) for LRC. The NOM approach involves deferral of surgery and active surveillance of all patients with LRC who have achieved a complete clinical response (i.e., have no residual tumour) following completion CRT which occurs in approximately 30% of patients. To date, while there have been a few, prospective single institution studies that have shown favourable results with NOM, this approach has not been adopted into clinical practice due to concerns from physicians about the safety of NOM based on the limited evidence available.

Objectives: Therefore, the objective of this study is to conduct a pan-Canadian Phase II trial to assess the safety of NOM for LRC.

Methods: All patients with LRC requiring surgery and a permanent colostomy being treated at the participating centres will be assessed for complete clinical response (cCR) eight to ten weeks following the completion of CRT by the treating surgeon. For the study, a cCR will be defined as (i) no palpable tumour on digital rectal exam, (ii) no residual tumour defined as white-yellow, flat scar on endoscopy, (iii) no residual tumour on MRI, (iv) no suspicious mesorectal or extramesorectal lymph nodes on MRI and (v) normal CEA level. Patients who meet all of these criteria for cCR will be invited to participate in the study. Patients who consent to participate in the study will undergo active surveillance that will include DRE, endoscopy and pelvic MRI every 3, 6, 9, 12, 18 and 24 months; CEA levels every 3, 6, 9, 12, 15, 18, 21, 24 months and CT chest/abdomen and pelvis every 6, 12, 18 and 24 months. The primary outcome for the study will be the rate of local re-growth 2 years following the completion of CRT. Local re-growth will be defined as failure to meet the cCR criteria at any time point. NOM will be considered safe, if the rate of local re-growth is less than 30% two years after the completion of CRT. The secondary outcomes for the study will be the rate of distant recurrence, disease free and overall survival at 2 years.

Significance: The results of this study will be highly clinically relevant since it is expected that NOM for LRC will be safe and will have significant potential to change clinical practice in Canada and North America since approximately 30% of patients with LRC would be able to safely avoid surgery and a permanent colostomy and have improved bowel and sexual function and body image. Furthermore, widespread adoption of NOM has the potential to increase health care capacity and decrease treatment costs by reducing the number of surgeries, hospital admissions and costs associated with both surgery and long term surgical morbidity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3L9
        • Recruiting
        • Sinai Health System
        • Contact:
          • Erin Kennedy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of local re-growth
Time Frame: 2 years
The safety of non-operative management will be evaluated by assessing the rate of local re-growth in the study population. This approach will be considered safe if the local re-growth rate is equal to or less than 30%.
2 years
Rate of macroscopically positive resection margin
Time Frame: 2 years
The safety of non-operative management will be evaluated by assessing the rate of macroscopically positive resection margin following surgery in the study population. This approach will be considered safe if the rate is 0%.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of overall survival
Time Frame: 2 years
Rate of overall survival in the study population assessed 2 years after completion of CRT
2 years
Rate of disease-free survival
Time Frame: 2 years
Rate of disease-free survival in the study population assessed 2 years after completion of CRT
2 years
Colostomy-free survival
Time Frame: 2 years
Rate of colostomy-free survival in the study population assessed 2 years after completion of CRT
2 years
Quality of Life
Time Frame: 6, 12, 24 months
Quality of life will be measured using the EORTC C30 questionnaire and will be assessed at 6, 12 and 24 months.
6, 12, 24 months
Bowel Function
Time Frame: 6, 12, 24 months
Bowel function will be measured using the MSKCC Bowel Function Instrument and will be assessed at 6, 12 and 24 months.
6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mount Sinai Hospital, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erin Kennedy, Sinai Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PJT - 148730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Neoplasms

Clinical Trials on Non-operative management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings