Non-operative Management for Locally Advanced Rectal Cancer

NCT03179540 | Recruiting DMC

• 1 other identifier: PJT - 148730
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of local re-growth

  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

  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 Outcomes (5)

• Rate of overall survival

  2 years

• Rate of disease-free survival

  2 years

• Colostomy-free survival

  2 years

• Quality of Life

  6, 12, 24 months

• Bowel Function

  6, 12, 24 months

Study Arms (1)

non-operative management

EXPERIMENTAL

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

Interventions

Non-operative management PROCEDURE

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.

non-operative management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Provides written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Sinai Health System

Toronto, Ontario, M5T 3L9, Canada

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Erin Kennedy

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Kennedy

CONTACT

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

Selina Schmocker

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: June 7, 2017
• Study Start: March 16, 2018
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)