Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: BreastQ questionnaire-; Radiation: Multi-Beam Intensity-Modulated Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01127373

10-025

Details and patient eligibility

About

This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.

Enrollment: 116 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female gender
• Age ≥18 years
• An invasive primary breast cancer of any histology arising from breast parenchyma
• Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection
• Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is 0.
• Patient signed study-specific consent form.

Exclusion criteria

• Patients with distant metastasis.
• Patients who are pregnant or breastfeeding.
• Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
• Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.
• Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.
• Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
• Primary breast cancer is a lymphoma or sarcoma histology.
• Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.
• Patients requiring radiation to the bilateral breasts.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

radiation therapy via multi-beam IMRT

Experimental group

Description:

This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.

Treatment:

Behavioral: BreastQ questionnaire-

Radiation: Multi-Beam Intensity-Modulated Radiation Therapy