Chemoradiation + Radiation Boost for Rectal Cancer
(Morpheus Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the treatment of chemoradiation with 5-FU or capecitabine generally safe for humans?
What makes the Chemoradiation + Radiation Boost treatment for rectal cancer unique?
What data supports the effectiveness of the drug Xeloda (capecitabine) for rectal cancer?
Who Is on the Research Team?
Te Vuong, MD
Principal Investigator
Sir Mortimer Jewish General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) followed by either an external beam boost of 9 Gy or a brachytherapy boost of 30 Gy in 3 fractions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for local recurrence and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- 5-FU
- Chemoradiation + EBRT Boost
- Chemoradiation + HDRBT Boost
- HDRBT Boost
- Xeloda
5-FU is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General Hospital
Lead Sponsor