Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment 6 gy/ fraction
Phase phase 1/phase 2
Sponsor New York University School of Medicine
Start date May 2000
End date September 2007
Trial size 100 participants
Trial identifier NCT02883985, 9096

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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.

Primary Outcomes

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

Secondary Outcomes

Measure
TGF-beta 1 determinations
time frame: From baseline to up to 4 weeks
Ultrasound for target localization
time frame: up to 4 weeks

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
Principal investigator Carmen Perez, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.