Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS (SPARTACUS)
Stereotactic Pelvic Adjuvant Radiation TherApy in Cancers of the UteruS): A Phase I/II Study (SPARTACUS)
Advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. A secondary result of these technologic advances has been the increased utilization of hypofractionationed treatment protocols, since the combined ability to better visualize and precisely deliver radiation to target volumes has allowed radiation oncologists to leverage the therapeutic ratio toward higher target doses whilst maintaining safe doses to the pertinent organs-at-risk. The spectrum of hypofractionation ranges from what are considered moderate (ie. 2- 5 Gy / fraction) into the realm of what is more commonly referred to as stereotactic body (SBRT), generally >5 Gy / fraction. There is growing evidence demonstrating both safety and efficacy for SBRT. The investigators propose that these advantages are translatable to the adjuvant treatment of endometrial cancer.
The investigators submit that a prescription dose of 30 Gy in 5 fractions. Through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Health Sciences Centre
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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:
- Histologically confirmed endometrial adenocarcinoma
Patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions:
- Patient has serous, clear cell, carcinosarcoma or differentiated histologies.
- Outer-half myometrial invasion and FIGO grade 1-2 OR
- FIGO stage II - IIIC1.
- Willing and able to give informed consent to participate in this clinical trial.
- Age ≥18 years.
- Are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments.
- Willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol.
- Primary language of the patient must be English or, if a patient's primary language is not English, they are still able to participate provided the QLQ-C30 and EN-24 is available in their primary language.
Exclusion Criteria:
- Has had prior pelvic radiotherapy.
- Has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease.
- Has a contraindication to iodinated CT contrast.
- Has a hip prosthesis.
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：他の
- 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：Hypofractionated Pelvic Radiation
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Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
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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 |
|---|---|---|
|
Acute toxicities
時間枠：Baseline to 12 weeks following RT completion
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To assess the acute urinary and bowel toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
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Baseline to 12 weeks following RT completion
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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 |
|---|---|---|
|
Quality of life through EORTC QLQ-C30 and EN24
時間枠：Study activation through 2 years post-RT
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To assess the effect of adjuvant SBRT treatment on acute and late patient reported health quality of life using EORTC questionnaires.
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Study activation through 2 years post-RT
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Late toxicities
時間枠：12 weeks post-RT to 2 years post-RT
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To assess the late urinary, bowel, and other toxicities associated with adjuvant SBRT treatment in the setting of high-risk endometrial cancer using CTCAE.
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12 weeks post-RT to 2 years post-RT
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Local-regional failure
時間枠：Study activation through 2 years post-RT
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To assess the local-regional failure of adjuvant SBRT treatment by observation of progression or persistence of disease.
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Study activation through 2 years post-RT
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Disease-free survival
時間枠：Study activation through 2 years post-RT
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To document the disease-free survival of those treated with adjuvant SBRT
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Study activation through 2 years post-RT
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Dosimetric feasibility
時間枠：Baseline to RT completion
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The number of patients eligible for enrollment at a 30Gy prescription dose based rigid dosimetric constraints, as compared to a 27.5 Gy treatment dose.
|
Baseline to RT completion
|
協力者と研究者
捜査官
- 主任研究者：Eric Leung, MD、Sunnybrook Health Sciences Centre
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
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