Breast Cancer Clinical Trial
Official title:
A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
NCT number | NCT01008514 |
Other study ID # | OSU-08177 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | November 4, 2009 |
Last updated | March 25, 2015 |
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near
a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in
treating women with early-stage breast cancer.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma - Stage 0, I, or II (T2, N0; tumor size = 3 cm) disease - Pathologic staging of the axilla preferred - Clinical staging of the axilla allowed for patients = 70 years of age with hormone receptor-positive tumors - Unicentric tumor - Microscopic multifocality allowed as long as the total tumor size is = 3 cm - Must have undergone lumpectomy as definitive surgery - Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery - Re-excision to obtain negative margins allowed - Must have adequate skin spacing between balloon surface and surface of the skin and lung (= 7 mm) - No multicentric carcinoma (invasive or DCIS) in more than one quadrant - No clinically or pathologically positive regional lymph nodes - No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing > 25% of the primary tumor - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Menopausal status not specified - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No collagen-vascular disease, including any of the following: - Dermatomyositis - Systemic lupus erythematosus - Scleroderma-mixed connective tissue disease PRIOR CONCURRENT THERAPY: - See Disease Characteristics |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of local recurrence | Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume. Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume. |
up to 5 years | No |
Secondary | Safety and toxicity | up to 30 months after radiotherapy | Yes | |
Secondary | Cosmetic results | up to 30 months | No |
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