Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00325598
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility of PBI Directed External Radiotherapy as Measured by Development of Histological Fat Necrosis or Other Grade 4 Skin or Grade 4 Subcutaneous Toxicity, or Requires Surgery for the Skin/Subcutaneous Toxicity Within 1 year of protocol registration -The study will be deemed infeasible if more than 4 patients develop histological fat necrosis or other grade 4 skin or grade 4 subcutaneous toxicity, or requires surgery for her skin or subcutaneous toxicity
Feasibility of PBI Directed External Radiotherapy as Measured by Percentage of Participants Achieving a Dosimetrically Satisfactory Treatment Plan Within 1 year of protocol registration -The study will be deemed infeasible if more than 4 patients cannot be given treatment because her tumor is such that a dosimetrically satisfactory treatment plan cannot be devised for her.
- Secondary Outcome Measures
Name Time Method Local Control Rate Up to 5 years -Local control rate for this study is the number of participants who remained free of disease in their breast.
Distant Control Rate Up to 5 years -Distant control rate for this study is the number of participants who remained free of cancer at distant sites which is defined as all parts of the body that are not the ipsilateral breast or ipsilateral regional lymph nodes.
Incidence and Severity of Cutaneous Toxicity Up to 5 years * Uses RTOG/EORTC Late Radiation Morbidity Scoring Scheme
* Grade 0 = none
* Grade 1 = slight atrophy; pigmentation change; some hair loss
* Grade 2 = patch atrophy; moderate telangiectasia; total hair loss
* Grade 3 = marked atrophy; gross telangiectasia
* Grade 4 = ulceration
* Worst cutaneous toxicity grade is notedIncidence of Fat Necrosis Up to 5 years -Fat necrosis typically causes a painless mass located superficially in the breast, accompanied by retraction or dimpling of the overlying skin. The skin may be thickened clinically and radiologically. Fat necrosis is firm and relatively circumscribed on palpation. Mammography usually reveals a spiculated, often poorly defined mass that may contain punctate or large, irregular calcifications. Attachment to the skin, dimpling, and thickening of the skin are often evident. Less frequently, the lesion consists of a circumscribed, oil-filled, partly calcified cyst. Early in its development, fat necrosis has the appearance of hemorrhage in indurated fat. After several weeks, the affected area becomes demarcated, forming a distinct yellow-gray and focally reddish tumor. Cystic degeneration may develop in the center of such a lesion, resulting in a cavity that contains oily fluid or necrotic fat.
Incidence of Breast Fibrosis Up to 5 years Regional Control Rate Up to 5 years -Regional control rate for this study is the number of participants who remained free from disease in the regional lymph nodes. The regional lymph nodes are the axilla, infraclavicular, supraclavicular, and internal mammary lymph node beds
Cosmetic Outcome Up to 5 years * Excellent: little or no observable change
* Good: minimal but identifiable changes
* Fair: significant results of radiotherapy noted
* Poor: severe normal tissue sequelae
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Washington University School of Medicine🇺🇸Saint Louis, Missouri, United States