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Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer

NCT03269981 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 827

Last updated 2023-11-27

No results posted yet for this study

Summary

This study evaluates the impact of elective regional lymph node irradiation on N1 breast cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone (WBI group).

Conditions

  • Breast Neoplasm

Interventions

RADIATION

Whole breast irradiation

Radiotherapy to the whole breast alone.

RADIATION

Whole breast and nodal irradiation

Radiotherapy to the whole breast and regional lymph nodes.

Sponsors & Collaborators

  • Korean Radiation Oncology Group

    collaborator UNKNOWN

  • Ministry of Health, Republic of Korea

    collaborator OTHER_GOV

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Won Park, MD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2029-12-30
Completion
2029-12-30

Countries

  • South Korea

Study Locations

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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 NCT03269981 on ClinicalTrials.gov