Actively Recruiting
MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
Led by Medical College of Wisconsin · Updated on 2026-03-16
22
Participants Needed
1
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open-label, phase I design.
CONDITIONS
Official Title
MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Pathologically confirmed adenocarcinoma of the rectum.
- Clinical stage I, II, or III determined by staging evaluation.
- No clear or biopsy-proven distant metastatic disease; equivocal small lung or liver lesions allowed as judged by tumor board.
- ECOG performance status 0 to 2 within 45 days before study entry.
- History and physical exam including weight and vital signs within 45 days prior to treatment.
- Mandatory rectal MRI for staging and follow-up.
- Chest CT scan within 45 days before study entry.
- Radiation treatment planning with abdominal CT and pelvic MRI simulation.
- Laboratory tests within 45 days prior to treatment meeting specific blood count and liver function criteria.
- Not on hemodialysis.
- Ability to swallow oral medications.
- Medical oncology approval as candidate for systemic chemotherapy.
- Signed study-specific informed consent.
- Negative pregnancy test if applicable.
- Women of childbearing potential and sexually active men must use adequate contraception.
You will not qualify if you...
- Biopsy-proven or high clinical suspicion of distant metastatic (stage IV) disease.
- Prior invasive malignancy except certain skin, breast, or prostate cancers under surveillance; other cancers must be disease-free for at least three years.
- Prior radiotherapy to the area overlapping study radiation fields.
- Major surgery within 28 days before study entry except certain procedures.
- Severe active comorbidities including unstable angina, recent heart attack, active infections needing IV antibiotics, recent respiratory hospitalizations, uncontrolled malabsorption, unresolved intestinal obstruction, AIDS, or any condition precluding major intestinal surgery.
- Pregnancy or unwillingness/inability to use effective contraception during and after study treatment.
- Participation in another interventional treatment trial.
- Use of nonprotocol chemotherapy or immune-modulating agents.
- Poor functional status preventing radiation positioning.
- Allergy to gadolinium.
- For participants over 60 with history of hypertension, diabetes, or liver transplant, a glomerular filtration rate below 30 excludes participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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