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Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

NCT02515110 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • Node-positive Breast Cancer
  • Breast Adenocarcinoma
  • Invasive Breast Carcinoma
  • Lobular Breast Carcinoma In Situ

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.

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Douglas W Arthur, M.D. · Massey Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-04
Primary Completion
2026-04-30
Completion
2028-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02515110 on ClinicalTrials.gov