Clinical trial NCT01127373: Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast
Radiation
Multi-Beam Intensity-Modulated Radiation
post mastectomy
post partial mastectomy
node-positive breast cancer
10-025
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
timeFrame: 5 weeks
Secondary outcomes:
measure: Number of Participants Evaluated for Acute and Late Cutaneous Toxicity
timeFrame: 5-7 months following the completion of radiation therapy
measure: Number of Participants Evaluated for Late Subcutaneous Fibrosis
timeFrame: 5-7 months following the completion of radiation therapy
measure: Mean FEV1 at Baseline
timeFrame: Baseline
measure: Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
timeFrame: Baseline
measure: Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
timeFrame: Baseline
measure: Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
timeFrame: Baseline
measure: Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
timeFrame: 6 months post radiation therapy
measure: Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
timeFrame: 6 months post radiation therapy
measure: Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
timeFrame: 6 months post radiation therapy
measure: Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
timeFrame: 6 months post radiation therapy
measure: Median Follow-up Period
timeFrame: up to 82 months post-radiation therapy
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Follow Up Only)
state: New Jersey
city: Middletown
country: United States
facility: Memoral Sloan Kettering Monmouth (Follow Up Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Follow Up Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Follow Up Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre (Follow Up Only)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Follow Up Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Simon Powell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.