← Back to Search

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

Must not have

Evidence of distant metastasis

Extension of malignant disease to the anal canal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years post treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My colon can be examined with a colonoscopy.

Select...

My rectal cancer has not spread to nearby lymph nodes.

Select...

My tumor is smaller than 5 cm.

Select...

I am older than 18 years.

Select...

My tumor is within 10 cm of the anal opening.

Select...

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

Select...

My tumor can be reached for internal radiation treatment.

Select...

My rectal cancer is at an early but invasive stage.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My cancer has spread to distant parts of my body.

Select...

My cancer has spread to the anal canal.

Select...

My cancer is at a stage where it has grown very large or spread to nearby tissues.

Select...

I have had radiation therapy in the pelvic area before.

Select...

My tumor is larger than 5 cm.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

TME-free survival

Secondary study objectives

Disease-free survival

Local Recurrence

Overall Quality of life

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 15Eligibility criteria met