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

NCT ID: NCT02883985

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2017-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

6 Gy/ fraction

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Perez, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Perlmutter Cancer Center

Locations

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NYU Perlmutter Cancer Center

New York, New York, United States

Site Status

Countries

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United States

References

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Formenti SC, Hsu H, Fenton-Kerimian M, Roses D, Guth A, Jozsef G, Goldberg JD, Dewyngaert JK. Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):606-11. doi: 10.1016/j.ijrobp.2012.01.039. Epub 2012 Apr 9.

Reference Type RESULT
PMID: 22494589 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/?term=Prone+accelerated+partial+breast+irradiation+after+breast-conserving+surgery%3A+Five+year+results+of+100+patients

Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients

Other Identifiers

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9096

Identifier Type: -

Identifier Source: org_study_id