No Surgery Trial / Two Dose-escalation Strategies (Morpheus)

February 12, 2026 updated by: Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer

A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. After interim analysis on 40 patients of the pilot study a phase III study is proposed. We are therefore proposing a phase III multicentric study of 145 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical response. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.

Study Type

Interventional

Enrollment (Estimated)

131

Phase

  • Phase 2
  • Phase 3

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 Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Te Vuong, MD
        • Contact:
      • Montreal, Quebec, Canada, H2X0A9
        • Recruiting
        • Le Centre Hospitalier de l'Université de Montreal
        • Principal Investigator:
          • Carole Richard, MD
        • Contact:
      • Québec, Quebec, Canada, G2L2Z3
        • Recruiting
        • Centre Hospitalier Universitaire de Quebec
        • Contact:
          • André-Guy Martin, MD
  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Aurelie Garant, MD

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound
  • Rectal cancer staged as N0 by MRI or EUS/TRUS
  • No metastatic lesion
  • Rectal tumor occupying less than half of the circumference
  • Tumor less than 5 cm on its largest dimension
  • Tumor located at less than 10 cm from the anal verge
  • Tumor penetration less than 5 mm in the mesorectal fat
  • Tumor accessible for brachytherapy
  • Lumen accessible for colonoscopy
  • Patient should be a suitable candidate for brachytherapy and chemotherapy
  • Older than 18 years of age
  • Adequate birth control measures in women of childbearing potential
  • Written informed consent

Exclusion Criteria:

  • Patients with previous pelvic radiation
  • Evidence of distant metastasis
  • Extension of malignant disease to the anal canal
  • Tumors staged as T4
  • Tumors larger than 5 cm in length

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoradiation + EBRT Boost
standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders
Procedure: Complete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
Radiation: Chemoradiation + EBRT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
Experimental: Chemoradiation + HDRBT Boost
standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions; Complete responders and Non-complete responders
Procedure: Complete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
Radiation: Chemoradiation + HDRBT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TME-free survival
Time Frame: 2 years post treatment
Time from date of randomization to either TME or death in the intention to treat population
2 years post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Recurrence
Time Frame: 2 years post treatment
Number of participants with Local recurrence as assessed by tests during follow-up visits.
2 years post treatment
Disease-free survival
Time Frame: 5 years post treatment
The time between the date of randomization and recurrence, either in the pelvis or metastases. Patients without an event will be censored at the last date the patient was known to be disease-free.
5 years post treatment
Overall survival
Time Frame: 5 years post treatment
The time between date of randomization and date of death due to any causes.
5 years post treatment
Overall Quality of life
Time Frame: 5 years post treatment
Quality of life Questionnaires over different time point
5 years post treatment

Collaborators and Investigators

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

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Investigators

  • Principal Investigator: Te Vuong, MD, Sir Mortimer Jewish General Hospital

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)

April 25, 2017

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-301

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.

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