Clinical trial NCT03786354: Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
Official title: Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
timeFrame: At 1 year
Secondary outcomes:
measure: Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)
timeFrame: At 1 year
measure: 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
timeFrame: At baseline, 1 month, 6 months and 12 months post-radiation
measure: Measure rates of upper extremity lymphedema using arm circumference with a tape measure
timeFrame: At baseline, 1 month, 6 months and 12 months post-radiation
measure: Measure rates of upper extremity lymphedema using a perometer
timeFrame: At baseline, 1 month, 6 months and 12 months post-radiation
measure: Dosimetric parameters associated with worse arm/shoulder morbidity as measured by the DASH
timeFrame: Up to 5 years
measure: Rates of loco-regional control in patients treated with IMRT
timeFrame: At 5 years
measure: Distant metastases in patients treated with IMRT
timeFrame: At 5 years
measure: Overall survival in patients treated with IMRT
timeFrame: Up to 5 years
measure: Shoulder/arm morbidity using the DASH questionnaire in patients treated with IMRT
timeFrame: Up to 5 years
measure: Shoulder/arm morbidity using the DASH questionnaire in patients treated with 3DCRT
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sasha Beyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: