RecruitingPhase 1NCT04808323

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


Sponsor

Medical College of Wisconsin

Enrollment

22 participants

Start Date

Jun 17, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open-label, phase I design.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an advanced form of radiation therapy — guided by MRI imaging in real time — for rectal cancer to see whether precise, adaptive treatment can shrink the tumor enough to avoid surgery altogether, preserving the rectum and quality of life. **You may be eligible if...** - You are 18 or older - You have rectal cancer confirmed by biopsy (adenocarcinoma) - Your cancer is Stage I, II, or III (has not spread to distant organs, or has only equivocal/uncertain distant findings) - You are a candidate for curative treatment **You may NOT be eligible if...** - You have confirmed distant metastases - You have inflammatory bowel disease - You have had prior pelvic radiation - You have a pacemaker or other MRI-incompatible implant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

825 mg/m\^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.

DEVICEInitial Dose of Radiation before Dose Escalation

50 Gy over 25 frac.

DEVICECohort A: Dose Escalation Radiation

Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.

DEVICECohort B: Dose Escalation Radiation

Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.

DEVICECohort C: Dose Escalation Radiation

Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.

DRUGFOLFOX

After the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)


Locations(1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT04808323


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