Trial record 1 of 1 for: non-operative management | rectal cancer | Canada

Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03179540

Recruitment Status : Recruiting

First Posted : June 7, 2017

Last Update Posted : January 18, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Mount Sinai Hospital, Canada

Study Description

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%.

Condition or disease	Intervention/treatment	Phase
Rectal Neoplasms	Procedure: Non-operative management	Not Applicable

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 Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer
Actual Study Start Date :	March 16, 2018
Estimated Primary Completion Date :	January 2021
Estimated Study Completion Date :	June 2021

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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%.
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%.

Secondary Outcome Measures :

Rate of overall survival [ Time Frame: 2 years ]
Rate of overall survival in the study population assessed 2 years after completion of CRT
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
Colostomy-free survival [ Time Frame: 2 years ]
Rate of colostomy-free survival in the study population assessed 2 years after completion of CRT
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.
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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179540

Contacts

Layout table for location contacts

Contact: Erin Kennedy	416-586-4800 ext 6872	erin.kennedy@sinaihealthsystem.ca
Contact: Selina Schmocker	416-586-4800 ext 2159	selina.schmocker@sinaihealthsystem.ca

Locations

Layout table for location information

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

Sponsors and Collaborators

Mount Sinai Hospital, Canada

Investigators

Layout table for investigator information

Principal Investigator:	Erin Kennedy	Sinai Health System

More Information

Layout table for additonal information

Responsible Party:	Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:	NCT03179540
Other Study ID Numbers:	PJT - 148730
First Posted:	June 7, 2017 Key Record Dates
Last Update Posted:	January 18, 2020
Last Verified:	January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Mount Sinai Hospital, Canada:


Low Rectal Cancer Complete Clinical Response Non-operative Management

Additional relevant MeSH terms:

Layout table for MeSH terms

Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site	Neoplasms Rectal Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

To Top