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MRI-Guided Adaptive Radiation Therapy for Rectal Cancer

This study is testing a new way to deliver radiation therapy for rectal cancer, aiming to preserve the organ. It involves using MRI (Magnetic Resonance Imaging) to guide higher doses of radiation directly to the tumor. You would also receive chemotherapy with Capecitabine (or Fluorouracil) during the initial radiation. The study is looking at how safe these higher radiation doses are and if they cause serious side effects. To join, you must be at least 18 years old and have stage I, II, or III rectal adenocarcinoma that has not spread to other parts of the body. The study plans to enroll 22 participants, but its current recruitment status is unclear.

Study design
This is a prospective, open-label, Phase I study. It is designed to find the maximum tolerated dose of radiation therapy.
What's involved
You would receive chemotherapy (Capecitabine or Fluorouracil) and radiation therapy over several weeks. The total number of radiation treatments would range from 32 to 36 fractions.
Compensation
Not stated in the trial record.
Follow-up
The study will measure serious side effects during radiation, up to about 11.5 to 12.1 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04808323

MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Medical College of Wisconsin
~22 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:CapecitabineInitial Dose of Radiation before Dose EscalationCohort A: Dose Escalation RadiationCohort B: Dose Escalation RadiationCohort C: Dose Escalation RadiationFOLFOX

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of subjects in Cohort A with serious adverse events during radiation.
Measured over Up to 11.5-week period
+2 more outcomes measured

Conditions

Rectal Adenocarcinoma

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Rectal Adenocarcinoma

NCT04808323

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • William Hall, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
  • Carrie Peterson, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Medical College of Wisconsin Cancer Center Clinical Trials Office
[email protected]
414-805-8900
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • The number of subjects in Cohort A with serious adverse events during radiation.Up to 11.5-week period

    This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.

  • The number of subjects in Cohort B with serious adverse events during radiation.Up to 11.5-week period

    This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.

  • The number of subjects in Cohort C with serious adverse events during radiation.Up to a 12.1-week period.

    This will be measured by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grades 3, 4 and 5 will be serious.