Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/23/2018 |
| Start Date: | May 2000 |
| End Date: | September 2017 |
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
effective over standard 6-week radiation treatment in patients with breast cancer
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.
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.
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.
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