Breast Cancer Clinical Trial
Official title:
Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
Verified date | December 2018 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2017 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Perlmutter Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
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):6 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 5 years | ||
Secondary | 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 | |
Secondary | 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 |
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