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

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: Breast Cancer
• Intervention / Treatment: Radiation: 6 Gy/ fraction

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TGF-beta 1 determinations	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	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

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Carmen Perez, M.D., NYU Perlmutter Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 9096