The Prostate Immobilization Device Study
調査の概要
詳細な説明
The investigator assessed the device position and location of the interface between rectum and prostate weekly during the course of treatment. This information was obtained using a conebeam CT scan on the treatment couch prior to a regularly scheduled radiation treatment. The conebeam CT scan is a standard tool for monitoring patient position and radiation treatment accuracy. Prior to each radiation treatment, the patient was placed in a vaclock immobilization device, then aligned with room lasers to skin tattoos. On board portal imaging was then employed using the KvKv match technique to place isocenter as simulated. For intact prostate treatment, alignment was made to implanted gold fiducial markers. For post prostatectomy patients, the alignment was to pelvic bony anatomy. After patient alignment was complete, a conebeam CT scan was obtained. The position of the anterior rectal wall and the interface between prostate and rectum was compared to the position of these structures at the time of simulation. Measurement was taken in the midline of the prostate gland between its base and apex of the maximum deviation of the rectum prostate interface from its position at the time of simulation. For post prostatectomy patients, a measurement was taken of the maximum deviation from simulation of interface between the rectum and the prostate bed/bladder. These measurements were recorded weekly by the treating radiation oncologist on the Physician Data Sheet.
The difficulty of device insertion, positioning and inflation was recorded daily by the treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(unable to insert). These results were summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
Patient expression of discomfort during device placement was recorded daily by treating personnel based on a scale in the PIDS Daily Radiation Therapist Questionnaire, from 1(none) to 5(intolerable). These responses will be summarized by the clinical study coordinators on the PIDS Radiation Therapist Summary.
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
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Wisconsin
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Racine、Wisconsin、アメリカ、53405
- Wheaton Francsican Cancer Care - All Saints
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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:
- 18 years of age or older
- Clinically localized T1-3 N0-1 M0 adenocarcinoma of the prostate
- Planned definitive radiation therapy
Exclusion Criteria:
- Prior proctectomy
- Rectal surgery within one year
- Proctitis
- Rectal carcinoma
- Anal Stenosis
- History of inflammatory bowel disease
- Scleroderma
- Systemic sclerosis
- Refusal of treatment with immobilization device
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 |
|---|---|
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アクティブコンパレータ：Miller enema air tip
The Miller enema air tip rectal balloon is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy.
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Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.
他の名前：
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アクティブコンパレータ：Radiadyne Immobilizer
The Radiadyne Immobilizer Treatment Device is inserted into the rectum prior to radiation simulation and also prior to each radiation treatment to immobilize prostate gland and displace rectal tissue during radiation therapy
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Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment
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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 |
|---|---|---|
|
Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.
時間枠：Up to 9 weeks
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Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment.
An average value will be determined for each patient.
An average of individual patient values will be determined for each immobilization device.
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Up to 9 weeks
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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 |
|---|---|---|
|
Difficulty of Insertion.
時間枠：Up to nine weeks
|
Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult).
An average score was obtained at completion of therapy for each patient.
At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .
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Up to nine weeks
|
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Patient Expression of Discomfort
時間枠：Up to nine weeks
|
Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable).
An average score was obtained at completion of therapy for each patient.
At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .
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Up to nine weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：James H Taylor, MD、Wheaton Franciscan Cancer Care - All Saints
研究記録日
主要日程の研究
研究開始
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
追加の関連 MeSH 用語
その他の研究ID番号
- 11-019-ASH
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?
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