Comparing Immobilisation Shells in Cranial Radiotherapy (CORIOLIS)
A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells.
Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.
調査の概要
状態
詳細な説明
Patients will be randomised into one of two groups, with group A acting as the control group using the investigators' standard 3--point closed--face shell, and group B using the 3--point open--face shell (experimental group). Each procedure is discussed with the patient before commencement. Patients will be positioned into the optimal treatment position and the shell will be fabricated as per manufacturer instructions by pre-treatment radiographers. This is followed by the patient having a planning CT scan of their head while wearing their shell to allows radiographers and doctors to localise and plan the treatment. At the end of this appointment, the patient will be asked to complete the first of three questionnaires regarding their experience of wearing the shell. Radiographers will be asked to complete a questionnaire of their experience of using the shell, and complete timing data for the procedures.
On the first day of treatment, radiographers will discuss the treatment process and side effects of treatment with the patient, and treatment will be delivered under current department protocols using linear accelerators (linacs). During the course of the treatment, radiographers will obtain 5 sets of verification images for the study, and these will be assessed for set-up errors as per current department policy. Where possible, treatment fields will be used to verify patient position to keep radiation doses from verification imaging as low as reasonably practicable (ALARP). Patients will be asked to complete two more questionnaires on their experience, one on their first day and one on their last day of treatment. Radiographers will also complete questionnaires on these days. Timing data will be obtained for all treatment fractions.
The patient's perspective of the planning and treatment processes will be almost identical to that of patients having cranial radiotherapy that are not in the trial. The only differences that will be observed will be the use of an open-face shell (for patients in group B), completion of three questionnaires, and additional verification imaging.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
London、イギリス、SW3 6JJ
- Royal Marsden Hospital NHS Foundation Trust
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-
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
Inclusion Criteria:
- patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
- 5 or more fractions of virtually simulated cranial radiotherapy
- treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions
Exclusion Criteria:
- patients unable to give informed consent
- patients requiring conformal or inverse-planned radiotherapy
- patients requiring stereotactic radiotherapy
- patients who have previously had cranial or head and neck radiotherapy
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
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As for arm description
|
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実験的：Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
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As for arm description
|
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 |
|---|---|---|
|
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
時間枠：within 2 weeks of completion of treatment
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Assessment of verification imaging to determine individual systematic and random errors.
Individual errors are collated to determine group systematic and random errors for comparison.
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within 2 weeks of completion of treatment
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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 |
|---|---|---|
|
Timing data
時間枠：within 2 weeks of patient completion of treatment
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Completion of data on time taken for setup, imaging, and total appointment time
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within 2 weeks of patient completion of treatment
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Assessment of imaging to determine intra-fraction motion
時間枠：within 2 weeks of patient completion of treatment
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Comparison of verification imaging with in-treatment imaging records to determine magnitude of intra-fraction motion.
These will be assessed per patient and compared between both groups.
|
within 2 weeks of patient completion of treatment
|
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Patient acceptance and tolerability of immobilisation shells (pre-treatment)
時間枠：within 2 weeks of patient completion of treatment
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Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during fabrication (moulding) and planning CT scan.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
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Patient acceptance and tolerability of immobilisation shells (1st fraction)
時間枠：within 2 weeks of patient completion of treatment
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Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during first radiotherapy treatment session.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
|
|
Patient acceptance and tolerability of immobilisation shells (last fraction)
時間枠：within 2 weeks of patient completion of treatment
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Patient completion of questionnaire to determine acceptance and tolerability of immobilisation shell during last radiotherapy treatment session.
All three patient questionnaires will be analysed separately and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
|
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Radiographer satisfaction of using immobilisation shells (pre-treatment)
時間枠：within 2 weeks of patient completion of treatment
|
Radiographer completion of questionnaire to determine satisfaction with fabrication and use of immobilisation shell during pre-treatment stages.
Pre-treatment and treatment questionnaires will be analysed individually and together to determine any differences between both groups.
|
within 2 weeks of patient completion of treatment
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Radiographer satisfaction of using immobilisation shells (treatment)
時間枠：within 2 weeks of patient completion of treatment
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Radiographer completion of questionnaire to determine satisfaction with use of immobilisation shell during treatment.
The same questionnaire is used at the first and last fraction of treatment.
Pre-treatment and treatment questionnaires will be analysed individually and together to determine any differences between both groups.
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within 2 weeks of patient completion of treatment
|
協力者と研究者
捜査官
- 主任研究者：Liam Welsh, PhD, FRCR、Royal Marsden NHS Foundation Trust
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
- CCR4362
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Group A: Closed-face shellの臨床試験
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University of Management and Technology Sialkot...招待による登録