Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers

December 20, 2018 updated by: NYU Langone Health

Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy

The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor.

Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Perlmutter Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menopausal women (at least 2 years without menstrual period):

hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.

  • Original tumor non-palpable (mammographically detected).
  • Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
  • N0 or sentinel node negative or N0 clinically if the tumor is <1 cm in size.
  • Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
  • Prescribed antihormonal therapy as part of their management.

Exclusion Criteria:

  • Previous radiation therapy to the ipsilateral breast.
  • Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
  • Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
  • Women with a diagnosis of multifocal breast cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation Therapy: 6 Gy/ fraction
All patients will be treated with 6 Gy /fraction delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.
Radiation: 6 Gy/ fraction

All patients will be treated with 6 Gy (measure of radiation dose) /fraction (each radiation session) delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.

In addition to routine care, patients may receive antihormonal drugs as part of your base line treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TGF-beta 1 determinations
Time Frame: From baseline to up to 4 weeks
Blood specimens will be collected by venipuncture, before starting treatment, immediately after the last treatment fraction
From baseline to up to 4 weeks
Ultrasound for target localization
Time Frame: up to 4 weeks
Ultrasound is ideal for imaging soft tissues unobstructed by bone and has been used successfully in conjunction with the treatment of prostate cancer to verify compliance between the daily location of the prostate and the planned location with respect to the treatment linear accelerator. By using ultrasound to image the post-operative tumor bed of the breast in "real-time", the operator may automatically align the tumor bed with treatment machine on each day of treatment
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Carmen Perez, M.D., NYU Perlmutter Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2000

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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