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Accelerated Intensity Modulated Radiation Therapy (AIMRT) to the Breast After Segmental Mastectomy

NCT02606708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2020-08-14

Study results available
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Summary

The primary purpose of this study is to determine the feasibility and tolerability of a regimen of accelerated (hypofractionated) Intensity Modulated Radiation Therapy (AIMRT) to the whole breast as part of breast preservation. In addition, the investigators want to prospectively collect blood specimens to: assess TGF-β polymorphisms to identify potential carriers at higher risk for post-treatment fibrosis; generate a blood specimen repository for future studies of other relevant polymorphisms. The study investigators also want to prospectively follow each treated woman yearly to assess long-term radiation sequelae of the current regimen by using the LENT/SOMA scores.

Conditions

Interventions

RADIATION

Accelerated intensity modulated radiation therapy (AIMRT)

Sponsors & Collaborators

Principal Investigators

  • Carmen Perez, MD · NYU Langone Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-20
Primary Completion
2016-06-02
Completion
2017-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02606708 on ClinicalTrials.gov