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Chemotherapy

Chemoradiation + Radiation Boost for Rectal Cancer (Morpheus Trial)

Phase 2 & 3

Recruiting

Led By Te Vuong, MD

Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No metastatic lesion

Lumen accessible for colonoscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post treatment

Awards & highlights

Morpheus Trial Summary

This trial is studying two different types of radiation therapy for rectal cancer.

Who is the study for?

This trial is for adults over 18 with early-stage rectal cancer that hasn't spread, can be seen via colonoscopy, and is within 10 cm of the anal verge. The tumor must be less than 5 cm, occupy less than half the circumference of the rectum, and not have penetrated deeply into surrounding fat. Participants need to use effective birth control if applicable.Check my eligibility

What is being tested?

The study compares two treatments after standard chemoradiation for rectal cancer: one group receives an external beam radiation boost (EBRT), while another gets a high-dose-rate brachytherapy boost (HDRBT). Patients are randomly assigned to either treatment arm.See study design

What are the potential side effects?

Potential side effects include those from radiation like skin irritation, fatigue, bowel issues; chemotherapy may cause nausea, low blood counts leading to infection risk or bleeding problems; brachytherapy might add localized pain or discomfort.

Morpheus Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread to other parts of my body.

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My colon can be examined with a colonoscopy.

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My rectal cancer has not spread to nearby lymph nodes.

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My tumor is smaller than 5 cm.

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I am older than 18 years.

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My tumor is within 10 cm of the anal opening.

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My cancer has spread less than 5 mm into the fat around my rectum.

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My tumor can be reached for internal radiation treatment.

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My rectal cancer is at an early but invasive stage.

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My rectal tumor affects less than half of the rectum's circumference.

Morpheus Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TME-free survival

Secondary outcome measures

Disease-free survival

Local Recurrence

Overall Quality of life

+1 more

Morpheus Trial Design

2Treatment groups

Experimental Treatment

Group I: Chemoradiation + HDRBT BoostExperimental Treatment2 Interventions

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

Group II: Chemoradiation + EBRT BoostExperimental Treatment2 Interventions

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

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor

55 Previous Clinical Trials

21,015 Total Patients Enrolled

Te Vuong, MDPrincipal InvestigatorSir Mortimer Jewish General Hospital

6 Previous Clinical Trials

292 Total Patients Enrolled

Media Library

5-FU (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03051464 — Phase 2 & 3

Rectal Cancer Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT03051464 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study only recruiting patients who are 45 years or older?

"This particular trial is meant for patients aged 18 to 80. However, there are 11 other trials for patients who are underage and 315 trials for patients that are elderly."

Answered by AI

Who meets the screening requirements for this particular research study?

"This study is looking for 145 individuals over the age of 18 who have rectal carcinoma. The most crucial inclusion criteria are as follows: The tumor cannot be located more than 10 cm away from the anal verge, the rectal cancer must be clinically staged as a T2 or T3 by MRI or endoscopic/trans-rectal ultrasound, the rectal cancer must be staged as an N0 by MRI or EUS/TRUS, there cannot be any metastatic lesions, the rectal tumor cannot occupy more than half the circumference, the tumor cannot be larger than 5 cm on its largest dimension, the tumor penetration in the"

Answered by AI

What are the benefits that patients might experience from participating in this clinical trial?

"The primary endpoint for this study will be TME-free survival rates two years after treatment. Additionally, the research team will also be measuring for overall survival, local recurrence, and changes in quality of life over time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

No Surgery Trial / Two Dose-escalation Strategies

Dr. Te Vuong 2017. "No Surgery Trial / Two Dose-escalation Strategies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03051464.