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

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.

Study Overview

• Status: Active, not recruiting
• 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; 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; Lymph Node Involvement
• Intervention / Treatment: Radiation: Intensity-Modulated Radiation Therapy; Radiation: 3-Dimensional Conformal Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologically proven diagnosis of breast cancer
• Patients that receive neoadjuvant systemic therapy (chemotherapy, anti-HER2 therapy, or endocrine therapy) are eligible
• History/physical examination within 60 days prior to study entry
• Patients who have undergone either a lumpectomy or mastectomy are eligible
• Patients that have undergone any type of breast reconstruction are eligible
• The interval between the date of last surgery or chemotherapy and registration must be =< 84 days
• Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of radiation therapy
• Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
• Patients must provide study specific informed consent prior to study entry

Exclusion Criteria:

• Clinical or radiologic evidence of distant metastases
• Patients with known unresected disease in the axillary apex or supraclavicular fossa
• Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ [LCIS] is eligible)
• Prior surgery to the ipsilateral shoulder for any condition
• Baseline impaired mobility of the ipsilateral shoulder from a condition not related to the breast cancer surgery as determined by the treating physician
• Non-epithelial breast malignancies such as sarcoma/lymphoma
• Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
• Medical, psychiatric, or other conditions that would prevent the patient from receiving the protocol therapy or providing informed consent
• Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
• Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (IMRT); Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.	Radiation: Intensity-Modulated Radiation Therapy; Undergo IMRT; Other Names: IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy
Experimental: Arm B (3DCRT); Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.	Radiation: 3-Dimensional Conformal Radiation Therapy; Undergo 3DCRT; Other Names: 3-dimensional radiation therapy; 3D CONFORMAL RADIATION THERAPY; 3D CRT; 3D-CRT; Conformal Therapy; Radiation Conformal Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)	DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity. The full scale range is 0-100.	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)	DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity. Patients that have a DASH score of ≥15 at 1 year post-treatment will be considered as having persistent shoulder morbidity.	At 1 year
Changes in shoulder range of motion for flexion, abduction, internal and external rotation using a goniometer as defined by the American Academy of Orthopedic Surgeons	Using a goniometer as defined by the American Academy of Orthopedic Surgeons to measure changes in shoulder range of motion for flexion, abduction, internal and external rotation	At baseline, 1 month, 6 months and 12 months post-radiation
Measure rates of upper extremity lymphedema using arm circumference with a tape measure	Measure rates of upper extremity lymphedema using arm circumference using a tape measure	At baseline, 1 month, 6 months and 12 months post-radiation
Measure rates of upper extremity lymphedema using a perometer	Measure rates of upper extremity lymphedema using arm circumference using a perometer	At baseline, 1 month, 6 months and 12 months post-radiation
Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH	Dosimetric parameters (the volume of shoulder receiving 5-50 Gy) associated with worse arm/shoulder morbidity as measured by the DASH	Up to 5 years
Rates of loco-regional control in patients treated with IMRT	Rates of loco-regional control, distant metastases, and overall survival in patients treated with IMRT	At 5 years
Distant metastases in patients treated with IMRT	The cumulative incidence of distant metastases at 5 years in patients treated with IMRT control, distant metastases	At 5 years
Overall survival in patients treated with IMRT	Kaplan-Meier method will be used to estimate the 5-year overall survival in patients treated with IMRT	Up to 5 years
Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT	DASH questionnaire in patients treated with IMRT to assess shoulder/arm morbidity using full scale range 0-100	Up to 5 years
Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT	DASH questionnaire in patients treated with 3DCRT to assess shoulder/arm morbidity	Up to 5 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sasha Beyer, MD, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OSU-18201; NCI-2018-02307 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No