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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Loïg VAUGIER, MD
- 전화번호: +33 2 40 67 99 00
- 이메일: Loïg.vaugier@ico.unicancer.fr
연구 장소
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Angers, 프랑스, 49055
- Institut de Cancérologie de l'Ouest
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연락하다:
- Jeremy COLLIAUX, MD
- 전화번호: +33 2 41 35 27 00
- 이메일: jeremy.colliaux@ico.unicancer.fr
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Avignon, 프랑스, 84918
- CLCC Ste Catherine - Institut du cancer Avignon/Provence
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연락하다:
- Pierre TREMOLIERES, MD
- 전화번호: +33 4 90 27 61 61
- 이메일: p.tremolieres@isc84.org
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Brest, 프랑스, 29200
- CHU de Brest
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연락하다:
- Francois LUCIA, MD
- 전화번호: +33 2 98 22 33 33
- 이메일: francois.lucia@univ-brest.fr
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La Roche-sur-Yon, 프랑스, 85000
- CHD Vendée
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연락하다:
- Emmanuelle REYGAGNE-VIERA, MD
- 전화번호: +33 2 51 44 61 61
- 이메일: emmanuelle.reygagne-viera@ght85.fr
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Le Havre, 프랑스, 76600
- Centre Gillaume le Conquérant
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연락하다:
- Paul LESUEUR, MD
- 전화번호: +33 2 35 13 66 13
- 이메일: p.lesueur@cglc.fr
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Le Mans, 프랑스, 72000
- Clinique Victor Hugo
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연락하다:
- Yoann POINTREAU, MD
- 전화번호: +33 2 55 46 37 00
- 이메일: essaispointreau@ilcgroupe.fr
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Lorient, 프랑스, 56322
- Groupe Hospitalier Bretagne Sud (GHBS)
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연락하다:
- Guillaume BERA, MD
- 전화번호: +33 2 97 06 90 90
- 이메일: g.bera@ghbs.bzh
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Rennes, 프랑스, 35760
- Institut de Cancérologie Radiothérapie Bretillien (ICRB)
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연락하다:
- Francois RIET, MD
- 전화번호: +33 2 99 23 33 33
- 이메일: francois.riet@icrb.fr
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Rouen, 프랑스, 76038
- Centre Henri Becquerel
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연락하다:
- Sébastien THUREAU, MD
- 전화번호: +33 2 32 08 22 22
- 이메일: sebastien.thureau@chb.unicancer.fr
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Saint-Herblain, 프랑스, 44805
- Institut de Cancérologie de l'Ouest
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연락하다:
- Martin LANGE, MD
- 전화번호: +33 2 40 67 99 00
- 이메일: martin.lange@ico.unicancer.fr
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수석 연구원:
- Martin LANGE, MD
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Saint-Nazaire, 프랑스, 44600
- Clinique Mutualiste de l'Estuaire
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연락하다:
- Vincent LIBOIS, MD
- 전화번호: +33 2 72 27 53 00
- 이메일: vincent.libois@hospigrandouest.fr
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St-Malo, 프랑스, 35400
- Clinique de la Côte d'Emeraude
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연락하다:
- Nicolas JAKSIC, MD
- 전화번호: +33 2 23 52 20 20
- 이메일: nicolas.jaksic@icrb.fr
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Tours, 프랑스, 37044
- CHRU Bretonneau
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연락하다:
- Astrid THOMIN, MD
- 전화번호: +33 2 47 47 47 76
- 이메일: a.thomin@chu-tours.fr
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Vannes, 프랑스, 56000
- Clinique Saint Yves
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연락하다:
- Osman EL KABBAJ, MD
- 전화번호: +33 2 97 62 50 00
- 이메일: o.elkabbaj@centre-st-yves.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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1-year Clinical Disease Control Rate
기간: 12 months after randomization
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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.
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12 months after randomization
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공동 작업자 및 조사자
수사관
- 수석 연구원: Loïg VAUGIER, MD, Institut de Cancérologie de l'Ouest
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .