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

NCT03786354 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: OSU-18201NCI-2018-02307
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Shoulder/arm morbidity assessed by DASH questionnaire in patients treated with 3-dimensional conformal radiation therapy (3DCRT)

  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

  At baseline, 1 month, 6 months and 12 months post-radiation

• Measure rates of upper extremity lymphedema using arm circumference with a tape measure

  At baseline, 1 month, 6 months and 12 months post-radiation

• Measure rates of upper extremity lymphedema 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

  Up to 5 years

Study Arms (2)

Arm A (IMRT)

EXPERIMENTAL

Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.

Radiation: Intensity-Modulated Radiation Therapy

Arm B (3DCRT)

EXPERIMENTAL

Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.

Radiation: 3-Dimensional Conformal Radiation Therapy

Interventions

Intensity-Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Arm A (IMRT)

3-Dimensional Conformal Radiation Therapy RADIATION

Undergo 3DCRT

Also known as: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy

Arm B (3DCRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Sasha Beyer, MD, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 26, 2018
• Study Start: January 9, 2019
• Primary Completion: February 6, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)