Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
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.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
Secondary
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.
After completion of study therapy, patients are followed up periodically for 5 years.
研究の種類
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of local recurrence
時間枠：up to 5 years
|
|
up to 5 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Safety and toxicity
時間枠：up to 30 months after radiotherapy
|
up to 30 months after radiotherapy
|
|
Cosmetic results
時間枠：up to 30 months
|
up to 30 months
|
協力者と研究者
捜査官
- 主任研究者：Edward Kim, MD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- OSU-08177
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。