Stereotactic Radiotherapy for SPinal Metastases With Limited Extent of Epidural Disease (SPEED-RT)
This study evaluates a new radiation treatment approach for patients with cancer that has spread to the spine (vertebral metastases) and involves limited extension around the spinal cord without causing compression (non-compressive epiduritis). This condition is common and can lead to serious complications, including pain and spinal cord compression, potentially affecting mobility and quality of life.
The current standard of care is conventional radiotherapy, which is effective for symptom relief but may provide limited long-term tumor control. As advances in cancer treatments have improved survival, there is an increasing need for treatment approaches that better prevent local tumor progression in the spine.
This randomized clinical trial compares standard radiotherapy with stereotactic radiotherapy (SRT), an advanced and highly precise radiation technique that delivers higher doses directly to the tumor while minimizing exposure to surrounding healthy tissues, including the spinal cord.
The primary objective is to determine whether SRT can improve local disease control while maintaining an acceptable safety profile. The study will evaluate the proportion of patients who are alive without spinal disease progression (including spinal cord compression or local tumor recurrence) at one year after treatment. Secondary outcomes include treatment-related side effects, time to disease progression, overall survival, quality of life, feasibility of delivering SRT within a defined timeframe, risk of vertebral fractures, and need for additional radiation treatment.
Eligible patients will have an estimated life expectancy greater than six months. Strict radiation dose constraints will be applied to minimize the risk of spinal cord injury, and patient safety will be closely monitored, including implementation of an early stopping rule in case of unexpected severe toxicity.
The hypothesis of the study is that stereotactic radiotherapy will improve local control of spinal metastases compared with standard radiotherapy, without increasing the risk of serious adverse effects.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Loïg VAUGIER, MD
- 電話番号：+33 2 40 67 99 00
- メール：Loïg.vaugier@ico.unicancer.fr
研究場所
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Angers、フランス、49055
- Institut de Cancérologie de l'Ouest
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コンタクト：
- Jeremy COLLIAUX, MD
- 電話番号：+33 2 41 35 27 00
- メール：jeremy.colliaux@ico.unicancer.fr
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Avignon、フランス、84918
- CLCC Ste Catherine - Institut du cancer Avignon/Provence
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コンタクト：
- Pierre TREMOLIERES, MD
- 電話番号：+33 4 90 27 61 61
- メール：p.tremolieres@isc84.org
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Brest、フランス、29200
- CHU de Brest
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コンタクト：
- Francois LUCIA, MD
- 電話番号：+33 2 98 22 33 33
- メール：francois.lucia@univ-brest.fr
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La Roche-sur-Yon、フランス、85000
- CHD Vendée
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コンタクト：
- Emmanuelle REYGAGNE-VIERA, MD
- 電話番号：+33 2 51 44 61 61
- メール：emmanuelle.reygagne-viera@ght85.fr
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Le Havre、フランス、76600
- Centre Gillaume le Conquérant
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コンタクト：
- Paul LESUEUR, MD
- 電話番号：+33 2 35 13 66 13
- メール：p.lesueur@cglc.fr
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Le Mans、フランス、72000
- Clinique Victor Hugo
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コンタクト：
- Yoann POINTREAU, MD
- 電話番号：+33 2 55 46 37 00
- メール：essaispointreau@ilcgroupe.fr
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Lorient、フランス、56322
- Groupe Hospitalier Bretagne Sud (GHBS)
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コンタクト：
- Guillaume BERA, MD
- 電話番号：+33 2 97 06 90 90
- メール：g.bera@ghbs.bzh
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Rennes、フランス、35760
- Institut de Cancérologie Radiothérapie Bretillien (ICRB)
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コンタクト：
- Francois RIET, MD
- 電話番号：+33 2 99 23 33 33
- メール：francois.riet@icrb.fr
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Rouen、フランス、76038
- Centre Henri Becquerel
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コンタクト：
- Sébastien THUREAU, MD
- 電話番号：+33 2 32 08 22 22
- メール：sebastien.thureau@chb.unicancer.fr
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Saint-Herblain、フランス、44805
- Institut de Cancérologie de l'Ouest
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コンタクト：
- Martin LANGE, MD
- 電話番号：+33 2 40 67 99 00
- メール：martin.lange@ico.unicancer.fr
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主任研究者：
- Martin LANGE, MD
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Saint-Nazaire、フランス、44600
- Clinique Mutualiste de l'Estuaire
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コンタクト：
- Vincent LIBOIS, MD
- 電話番号：+33 2 72 27 53 00
- メール：vincent.libois@hospigrandouest.fr
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St-Malo、フランス、35400
- Clinique de la Côte d'Emeraude
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コンタクト：
- Nicolas JAKSIC, MD
- 電話番号：+33 2 23 52 20 20
- メール：nicolas.jaksic@icrb.fr
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Tours、フランス、37044
- CHRU Bretonneau
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コンタクト：
- Astrid THOMIN, MD
- 電話番号：+33 2 47 47 47 76
- メール：a.thomin@chu-tours.fr
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Vannes、フランス、56000
- Clinique Saint Yves
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コンタクト：
- Osman EL KABBAJ, MD
- 電話番号：+33 2 97 62 50 00
- メール：o.elkabbaj@centre-st-yves.fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Histologically confirmed solid tumor;
- Vertebral bone metastasis located between C2 and S1 (inclusive) with epiduritis (spinal cord or cauda equina) without clinical and/or radiological spinal cord compression on MRI;
- Performance status (PS) ≤ 1;
- Spinal Instability Neoplastic Score (SINS) ≤12;
- Patient has been informed and has provided freely given, written, and signed informed consent;
- Patient is affiliated with or a beneficiary of the national health insurance system.
Exclusion Criteria:
- Neurological deficit attributable to spinal cord compression or cauda equina syndrome;
- Patient experiencing pain that prevents lying down for 30 minutes despite optimal analgesic treatment;
- Life expectancy ≤6 months as estimated by the investigator;
- Neurosurgical indication (preventive or decompressive) prior to radiotherapy;
- More than one epiduritis lesion requiring treatment;
- Prior surgery on the same vertebra targeted in the protocol;
- Epiduritis and/or bone lesion extending over more than three contiguous vertebral levels;
- Previous irradiation of the spine with cumulative dose with cumulative spinal cord dose EQD2 >50 Gy, α/β = 2;
- Contraindication to MRI;
- Pregnant or breastfeeding woman;
- Patient under legal protection, guardianship, or unable to provide informed consent;
- Inability to comply with study follow-up due to geographic, social, or psychological reasons.
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 |
|---|---|
|
実験的：Stereotactic Body Radiotherapy (SBRT)
Participants will receive SBRT in 5 fractions. Treatment includes:
Treatment planning will follow current guidelines with strict spinal cord and cauda equina dose constraints. |
Stereotactic body radiotherapy delivered in 5 fractions, consisting of 20 Gy to the involved vertebra and spinal canal (including adjacent hemi-vertebrae) with a simultaneous integrated boost to 35 Gy in 5 fractions to the tumor volume, according to protocol-defined delineation and dose constraints.
|
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アクティブコンパレータ：Conventional Radiotherapy (palliative dose)
Participants will receive conventional external beam radiotherapy delivered in 5 fractions, with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent superior and inferior hemi-vertebrae, consistent with standard palliative treatment. Radiotherapy will be administered according to the standard practice of the investigating center, with attention to treating any epidural extension visible on MRI. This arm is not intended for formal efficacy comparison but will support interpretation of study results and inform the design of a future comparative superiority trial if SRT demonstrates sufficient efficacy. |
Conventional external beam radiotherapy delivered in 5 fractions with a total dose of 20 Gy to the involved vertebra and spinal canal, including adjacent hemi-vertebrae, in accordance with standard palliative practice.
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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 |
|---|---|---|
|
1-year Clinical Disease Control Rate
時間枠：12 months after randomization
|
Proportion of participants who are alive 12 months after randomization without clinical progression of the treated spinal lesion and without neurological deterioration attributable to the treated lesion during the 12-month follow-up.
|
12 months after randomization
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協力者と研究者
捜査官
- 主任研究者：Loïg VAUGIER, MD、Institut de Cancérologie de l'Ouest
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
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。