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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

116

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline

Completed

Started May 2010

Longer than P75 for not_applicable breast-cancer

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.4 years study duration

Study Start

First participant enrolled

May 11, 2010

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed

9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

April 20, 2021

Completed

Last Updated

April 20, 2021

Status Verified

October 1, 2019

Enrollment Period

9.4 years

First QC Date

May 19, 2010

Results QC Date

August 19, 2020

Last Update Submit

March 25, 2021

Conditions

Breast Cancer

Keywords

BreastRadiationMulti-Beam Intensity-Modulated Radiationpost mastectomypost partial mastectomynode-positive breast cancer10-025

Outcome Measures

Primary Outcomes (1)

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 Outcomes (11)

Number of Participants Evaluated for Acute and Late Cutaneous Toxicity
5-7 months following the completion of radiation therapy
Number of Participants Evaluated for Late Subcutaneous Fibrosis
5-7 months following the completion of radiation therapy
Mean FEV1 at Baseline
Baseline
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
Baseline
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
Baseline
+6 more secondary outcomes

Study Arms (1)

radiation therapy via multi-beam IMRT

EXPERIMENTAL

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: Multi-Beam Intensity-Modulated Radiation TherapyBehavioral: BreastQ questionnaire-

Interventions

Multi-Beam Intensity-Modulated Radiation TherapyRADIATION

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.

radiation therapy via multi-beam IMRT

BreastQ questionnaire-BEHAVIORAL

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.

radiation therapy via multi-beam IMRT

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Centerlead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Follow Up Only)

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Monmouth (Follow Up Only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack (Follow Up Only)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Follow Up Only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre (Follow Up Only)

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau (Follow Up Only)

Uniondale, New York, 11553, United States

Location

Related Publications (1)

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.
PMID: 30508620DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title: Dr. Simon Powell, MD
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Simon Powell, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 20, 2010

Study Start

May 11, 2010

Primary Completion

October 2, 2019

Study Completion

October 2, 2019

Last Updated

April 20, 2021

Results First Posted

April 20, 2021

Record last verified: 2019-10

Locations

US(7)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

radiation therapy via multi-beam IMRT

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

radiation therapy via multi-beam IMRT

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations