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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Multi-Beam Intensity-Modulated Radiation Therapy; Behavioral: BreastQ questionnaire-

• Registration Number: NCT01127373
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-11
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Status Verified: 2019-10
• Primary Completion: 2019-10-02
• Study Completion: 2019-10-02
• Results First Submitted: 2020-08-19
• Results First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Results First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 116

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiation therapy via multi-beam IMRT	Multi-Beam Intensity-Modulated Radiation Therapy	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.
radiation therapy via multi-beam IMRT	BreastQ questionnaire-	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.

Primary Outcome Measures

Name	Time	Method
Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification	5 weeks	The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients.

Secondary Outcome Measures

Name	Time	Method
Mean FEV1 at Baseline	Baseline	Participants FEV1 (forced expiratory volume in 1 second) measured at baseline
Number of Participants Evaluated for Acute and Late Cutaneous Toxicity	5-7 months following the completion of radiation therapy	Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.
Number of Participants Evaluated for Late Subcutaneous Fibrosis	5-7 months following the completion of radiation therapy	The radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system.
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)	6 months post radiation therapy	Severity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants 6 months from baseline.
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score	6 months post radiation therapy	Mean Community-Acquired Pneumonia/CAP scores will be taken at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a "CAP score." Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100.
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)	6 months post radiation therapy	Participant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy
Median Follow-up Period	up to 82 months post-radiation therapy	Median follow-up period of the enrolled cohort

Trial Locations

Locations (7)

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 Rockville Centre (Follow Up Only); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Commack (Follow Up Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau (Follow Up Only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Westchester (Follow Up Only); 🇺🇸 Harrison, New York, United States