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Not Yet Recruiting NCT05731791

A Prospective Randomized Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation

Conditions: Breast Cancer

Sex: Female
Ages: 50 Years – 90 Years
Phase: PHASE3
Enrollment: 380
Sponsor: Weill Medical College of Cornell University

Location: United States

Summary

The Investigators are investigating the potential role of MRI-guided Radiation Therapy for patients receiving breast radiotherapy in the prone position with a MRI-Linac radiotherapy system, the Precision Prone Irradiation (PPI) technique.Hypothesis: The investigators would like to hypothesize that breast radiation therapy using MRI-guided system including the MRI-Linac (Arm 2) is comparable to the current standard of treatment using conventional CT-based system (Arm 1), in terms of local control of the disease at 2 year time point.

Eligibility Criteria

Patients ≥ 50 yrs with histologically confirmed unilateral DCIS or Stage I invasive breast cancer; received breast conserving surgery (pN0 or pNx) with tumor pathology ≤ 2 cm and excision margin ≥ 1 mmInclusion Criteria:Women status post segmental mastectomyIf unilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.If bilateral, pT1 breast cancer excised with negative margins AND/OR pTis excised with negative margins.Clinically N0 or pN0 or sentinel node negativeDuctal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).Exclusion Criteria:Previous radiation therapy to the ipsilateral breast.> 90 days from last surgery, unless s/p adjuvant chemotherapy> 60 days from last chemotherapyPatients unable to tolerate MRI or are otherwise unsuitable for MRI-based RT treatmentMetastatic disease

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05731791). StuddyBuddy aggregates publicly available trial information.