Long Term Outcomes of Breast Intensity-Modulated Radiation Therapy (BIMRT)
Long Term Outcomes of A Multicentre Controlled Clinical Trial of Breast Irradiation Using Intensity-Modulated Radiation Therapy
調査の概要
詳細な説明
The Canadian breast IMRT clinical trial accrued 358 subjects between July 2003 to March 2005. Those subjects were randomised between standard radiotherapy using 2D wedge compensation and breast IMRT. Subjects were treated in Toronto, Ontario, or in Victoria, British Columbia. Subjects and assessors were carefully blinded to the treatment arm. The clinical trial was funded by the Canadian Institute for Health Research (CIHR) and one of the four objectives of the application was to "To record late skin toxicity occurrence, fibrosis and telangiectasia, in women receiving breast IMRT and conventional irradiation technique".
The investigators are proposing to invite women who participated in the trial to return to their treatment centre during 2011-2013 for a follow-up assessment at eight years after randomisation to record relevant long-term outcomes including the effect of improved homogeneity with IMRT on the occurrence of late radiation therapy side-effects cosmetic outcome and Quality of Life.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
British Columbia
-
Victoria、British Columbia、カナダ、V8R6V5
- BCCA - Vancouver Island Cancer Centre
-
-
Ontario
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Toronto、Ontario、カナダ、M4N 3M5
- Odette Cancer Centre
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Subject randomised in the initial breast IMRT randomized trial will be eligible for this new study
Exclusion Criteria:
- Subjects who have experienced a recurrence (invasive or in situ) in the breast will be excluded.
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
- 観測モデル：ケースのみ
- 時間の展望：回顧
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 |
|---|---|---|
|
Does breast IMRT reduces the occurrence of chronic breast pain after radiation therapy.
時間枠：8 years post RT
|
A Self pain measurement questionnaire using Visual analog scale (VAS) The nurse coordinator will assess the subject's breast pain due to radiation using the CTCAE 4.0 scale Subjects will complete a Self pain measurement short form of the McGill pain questionnaire
|
8 years post RT
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Does breast IMRT reduce the occurrence of late radiation therapy side effects
時間枠：8 years post RT
|
A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts. Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire |
8 years post RT
|
|
Does breast IMRT effect long term QOL
時間枠：8 Years post RT
|
A EORTC Breast Cancer Rating System for the cosmetic assessment RTOG/EORTC Late Radiation Morbidity Scoring Scheme Cosmetic outcome of the treated breast as compared with the untreated using the Harvard criteria Digital images (photographs) will be taken of the treated and untreated breasts. Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire |
8 Years post RT
|
|
Does IMRT effect local recurrence rates, overall and disease free survivals.
時間枠：8 years post RT
|
Data collection of local recurrences, overall and disease free survivals.
|
8 years post RT
|
協力者と研究者
捜査官
- 主任研究者：Jean-Philippe Pignol, MD、Odette Cancer Centre
- 主任研究者：Pauline Truong, MD、BCCA - Vancouver Island Cancer Centre
- 主任研究者：Ivo Olivotto, MD、BCCA - Vancouver Island Cancer Centre
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- BCCABreastIMRT
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。