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

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: NCT03051464
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Dr. Te Vuong, Sir Mortimer B. Davis - Jewish General Hospital

Brief Summary:
A randomized study of 145 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).

Condition or disease Intervention/treatment Phase
Stage II Rectal Cancer Procedure: Complete responders and Non-complete responders Radiation: Chemoradiation + EBRT Boost Radiation: Chemoradiation + HDRBT Boost Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2027

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Local Recurrence [ Time Frame: 2 years post treatment ]
    Number of participants with Local recurrence as assessed by tests during follow-up visits.

  2. 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.

  3. Overall survival [ Time Frame: 5 years post treatment ]
    The time between date of randomization and date of death due to any causes.

  4. Overall Quality of life [ Time Frame: 5 years post treatment ]
    Quality of life Questionnaires over different time point



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03051464


Contacts
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Contact: Emma Starr, BHSc 514-340-8222 ext 28443 emma.starr.ccomtl@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Emma Starr, BHSc    514-340-8222 ext 28443    emma.starr.ccomtl@ssss.gouv.qc.ca   
Principal Investigator: Te Vuong, MD         
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: Te Vuong, MD Sir Mortimer Jewish General Hospital
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Responsible Party: Dr. Te Vuong, Director, Radiation Oncology Department, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03051464    
Other Study ID Numbers: 16-301
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases