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

Breast Cancer Clinical Trial

Official title:

Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127373
• Other study ID #: 10-025
• Status: Completed
• Phase: N/A
• Start date: May 11, 2010
• Est. completion date: October 2, 2019

Study information

• Verified date: October 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: October 2, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Follow Up Only)	Basking Ridge	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	Memoral Sloan Kettering Monmouth (Follow Up Only)	Middletown	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification	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.	5 weeks
Secondary	Number of Participants Evaluated for Acute and Late Cutaneous Toxicity	Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.	5-7 months following the completion of radiation therapy
Secondary	Number of Participants Evaluated for Late Subcutaneous Fibrosis	The radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system.	5-7 months following the completion of radiation therapy
Secondary	Mean FEV1 at Baseline	Participants FEV1 (forced expiratory volume in 1 second) measured at baseline	Baseline
Secondary	Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)	Severity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants at baseline	Baseline
Secondary	Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)	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	Baseline
Secondary	Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score	Mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again 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.	Baseline
Secondary	Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)	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	6 months post radiation therapy
Secondary	Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)	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.	6 months post radiation therapy
Secondary	Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)	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	6 months post radiation therapy
Secondary	Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score	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.	6 months post radiation therapy
Secondary	Median Follow-up Period	Median follow-up period of the enrolled cohort	up to 82 months post-radiation therapy

External Links

•   Memorial Sloan-Kettering Cancer Center