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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02883985

Collaborator

(none)

100

Enrollment

Location

Arm

208

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: 6 Gy/ fraction	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Up to 5 years]

Secondary Outcome Measures

TGF-beta 1 determinations [From baseline to up to 4 weeks]
Blood specimens will be collected by venipuncture, before starting treatment, immediately after the last treatment fraction
Ultrasound for target localization [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Perlmutter Cancer Center	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02883985

Other Study ID Numbers:

9096

First Posted:

Aug 30, 2016

Last Update Posted:

Dec 21, 2018

Last Verified:

Dec 1, 2018

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Dec 21, 2018