Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer
NCT ID: NCT01127373
Last Updated: 2021-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2010-05-11
2019-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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radiation therapy via multi-beam IMRT
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.
Multi-Beam Intensity-Modulated Radiation Therapy
IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-
MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
Interventions
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Multi-Beam Intensity-Modulated Radiation Therapy
IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
BreastQ questionnaire-
MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Simon Powell, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Follow Up Only)
Basking Ridge, New Jersey, United States
Memoral Sloan Kettering Monmouth (Follow Up Only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack (Follow Up Only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Follow Up Only)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Rockville Centre (Follow Up Only)
Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau (Follow Up Only)
Uniondale, New York, United States
Countries
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References
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Ho AY, Ballangrud A, Li G, Gupta GP, McCormick B, Gewanter R, Gelblum D, Zinovoy M, Mueller B, Mychalczak B, Dutta P, Borofsky K, Parhar P, Reyngold M, Braunstein LZ, Chawla M, Krause K, Freeman N, Siu CT, Cost Z, Arnold BB, Zhang Z, Powell SN. Long-Term Pulmonary Outcomes of a Feasibility Study of Inverse-Planned, Multibeam Intensity Modulated Radiation Therapy in Node-Positive Breast Cancer Patients Receiving Regional Nodal Irradiation. Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1100-1108. doi: 10.1016/j.ijrobp.2018.11.045. Epub 2018 Nov 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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10-025
Identifier Type: -
Identifier Source: org_study_id
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