NCT03786354

Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer

Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the shoulder morbidity in patients with lymph-node positive breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal radiation therapy. Intensity modulated radiation therapy may cause less shoulder/arm morbidity in patients with lymph-node positive breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine if intensity modulated radiation therapy (IMRT) reduces average 1-year patient-reported shoulder/arm morbidity in women receiving regional nodal irradiation (RNI) for lymph-node positive breast cancer as compared to historical data. SECONDARY OBJECTIVES: I. To measure patient-reported shoulder/arm morbidity in women receiving RNI with 3-dimensional conformal radiation therapy (3DCRT) for lymph-node positive breast cancer. II. To measure change in shoulder range of motion in women receiving RNI. III. To measures rates of ipsilateral upper extremity lymphedema in women receiving RNI. IV. To explore the dose volume parameters to the shoulder/neck/trunk musculature associated with worsening patient-reported shoulder/arm morbidity. V. To assess disease outcomes in patients treated with IMRT. VI. To measure long-term patient-reported shoulder/arm morbidity in women receiving RNI with IMRT or 3DCRT. OUTLINE: Patients are assigned to 1 of 2 arms. ARM A: Patients undergo IMRT over 5 weeks. ARM B: Patients undergo 3DCRT over 5 weeks. After completion study treatment, patients are followed up at 1, 6, and 12 months, and then annually for up to 5 years.

Conditions

• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage IIA Breast Cancer AJCC v8
• Anatomic Stage IIB Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Lymph Node Involvement
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8

Interventions

Type	Name	Description
RADIATION	3-Dimensional Conformal Radiation Therapy	Undergo 3DCRT
RADIATION	Intensity-Modulated Radiation Therapy	Undergo IMRT

Timeline

• Start date: 2019-01-09
• Primary completion: 2026-02-06
• Completion: 2026-12-31
• First posted: 2018-12-26
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study