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ACTIVE NOT RECRUITING
NCT02515110
NA

Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction. Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.

Official title: Hypofractionated Regional Nodal Irradiation Phase 2 Clinical Trial for Women With Breast Cancer - HeNRIetta

Key Details

Gender

FEMALE

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

137

Start Date

2015-08-04

Completion Date

2028-04-30

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

RADIATION

External Beam Radiation Therapy

Breast or chest wall irradiation with hypofractionated regional nodal irradiation (RNI) will be delivered according to a hypofractionated treatment schedule of 16 fractions followed by boost of 4 to 6 fractions for patients who had a lumpectomy; a boost of 4 to 6 fractions may also be required for patients who had a mastectomy (with or without reconstruction) if the surgical margin is \< 2 mm.

Locations (2)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

VCU Community Memorial Healthcenter

South Hill, Virginia, United States