Proton Beam Radiation Therapy in Treating Patients With Breast Cancer

Status Recruiting

Clinical Trial Summary

This randomized phase II trial studies how well proton beam radiation therapy works in treating patients with breast cancer after surgery. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine whether the 24 month complication rate (defined as grade 3 or greater late adverse events; and unplanned surgical intervention in patients who undergo mastectomy with reconstruction) of 15 fraction chest wall and regional node pencil beam scanning proton radiotherapy is acceptable relative to 25 fraction chest wall and regional nodal pencil beam scanning proton radiotherapy and worthy of further investigation.

SECONDARY OBJECTIVES:

I. To evaluate acute and late toxicity. II. To evaluate the rate of reconstruction failure (defined as loss of the tissue expander or implant with the inability to replace it resulting in no final reconstruction or conversion to autologous reconstruction or unplanned revision with the addition of autologous reconstruction).

III. To determine the 5-year locoregional control, disease free survival and overall survival.

IV. To evaluate fatigue, arm function, and other patient reported outcomes. V. To evaluate clinical features, treatment technique, dose-volume parameters, histologic and genetic variants associated with fair and poor cosmetic outcome or unplanned surgical intervention.

VI. To compare echocardiographic changes, including left ventricular strain pattern, between fractionation regimens.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients receive conventionally fractionated proton beam radiation therapy daily for 25 fractions.

ARM II: Within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients receive hypofractionated proton beam radiation therapy daily for 15 fractions.

After completion of study treatment, patients are followed up at 12 weeks, at 12, 24, and 36 months, and at 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03391453
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Recruiting
Phase	Phase 2
Start date	May 10, 2016
Completion date	May 15, 2022

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Proton Beam Radiation Therapy in Treating Patients With Breast Cancer After Surgery

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms