A Registry Study of Permanent Breast Seed Implant
2021年10月22日 更新者：Dr. Eric Leung、Sunnybrook Health Sciences Centre
A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.
The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.
調査の概要
詳細な説明
For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.
Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.
研究の種類
介入
入学 (実際)
420
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Toronto、Ontario、カナダ、M4N3M5
- Sunnybrook Odette Cancer Centre
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- A confirmed histological diagnosis of invasive breast carcinoma
- Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
- Surgical margins clear over or equal to 2 mm
- A maximum tumor size of 3 cm
- Age >= 50 years old
- ECOG performance status of 0 or 1
- Informed consent signed
Exclusion Criteria:
- Previous history of cancer other than curable skin SCC or Tis or T1 cervix
- Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
- Autoimmune disorder
- Diabetes insulin-dependant
- Pregnancy
- Breast implants
- Psychiatric or addictive disorder that would preclude attending follow-up
- Post-operative breast infection
- Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- Lobular features on histology (pure or mixed) or sarcoma histology
- Node positive on axillary dissection or in the sentinel lymph node biopsy
- Extensive in situ carcinoma
- Multicentric disease (in more than one quadrant or separated by 2 cm or more)
- Paget's disease of the nipple
- Metastases
- Patients presenting a post-surgical fluid cavity ≥ 2.5 cm in diameter in any dimension as determined on the planning US
- Clear delineation of the target volume on CT is not possible
- Having a volume to be implanted over 120cc
- Having a target volume too close to skin such that the 85% isodose overlaps the skin surface)
- Having a target volume too close to the chest wall, such that there is a risk of perforating the chest wall
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：PBSI
PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.
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Patients are pre-planned using CT simulation.
Implant is realised under light sedation and local freezing.
Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle.
Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
他の名前：
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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 |
|---|---|---|
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Serious Adverse Events
時間枠：Initial and then yearly up to 5 years
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Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death.
SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
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Initial and then yearly up to 5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Breast cancer local recurrence
時間枠：Yearly up to 10 years
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Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.
Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.
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Yearly up to 10 years
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Regional recurrence
時間枠：Yearly up to 10 years
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Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection.
The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration.
Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).
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Yearly up to 10 years
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Metastases
時間枠：Yearly up to 10 years
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Distant recurrence is defined as evidence of tumor in any area of the body.
The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration
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Yearly up to 10 years
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PBSI side effects
時間枠：After procedure
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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After procedure
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PBSI side effects
時間枠：At 2 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 2 months
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PBSI side effect
時間枠：At 6 months
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
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At 6 months
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PBSI side effect
時間枠：Yearly up to 10 years
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Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).
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Yearly up to 10 years
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Cosmetic outcome
時間枠：Yearly up to 10 years
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Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist.
An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects).
A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast.
A fair score means significant radiation effects were readily observable.
A poor score is used for severe sequelae of breast tissue secondary to radiation effects.
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Yearly up to 10 years
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Survival
時間枠：Yearly up to 10 years
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Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.
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Yearly up to 10 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Eric Leung, MD、Sunnybrook Health Sciences Centre
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Pignol JP, Keller B, Rakovitch E, Sankreacha R, Easton H, Que W. First report of a permanent breast 103Pd seed implant as adjuvant radiation treatment for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):176-81. doi: 10.1016/j.ijrobp.2005.06.031. Epub 2005 Sep 22.
- Keller BM, Pignol JP, Rakovitch E, Sankreacha R, O'Brien P. A radiation badge survey for family members living with patients treated with a (103)Pd permanent breast seed implant. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):267-71. doi: 10.1016/j.ijrobp.2007.08.006. Epub 2007 Oct 29.
- Keller B, Sankreacha R, Rakovitch E, O'brien P, Pignol JP. A permanent breast seed implant as partial breast radiation therapy for early-stage patients: a comparison of palladium-103 and iodine-125 isotopes based on radiation safety considerations. Int J Radiat Oncol Biol Phys. 2005 Jun 1;62(2):358-65. doi: 10.1016/j.ijrobp.2004.10.014.
- Pignol JP, Rakovitch E, Keller BM, Sankreacha R, Chartier C. Tolerance and acceptance results of a palladium-103 permanent breast seed implant Phase I/II study. Int J Radiat Oncol Biol Phys. 2009 Apr 1;73(5):1482-8. doi: 10.1016/j.ijrobp.2008.06.1945. Epub 2008 Oct 18.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年3月1日
一次修了 (実際)
2018年1月19日
研究の完了 (実際)
2018年1月19日
試験登録日
最初に提出
2010年4月9日
QC基準を満たした最初の提出物
2010年4月19日
最初の投稿 (見積もり)
2010年4月20日
学習記録の更新
投稿された最後の更新 (実際)
2021年10月29日
QC基準を満たした最後の更新が送信されました
2021年10月22日
最終確認日
2021年10月1日
詳しくは
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。