A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas. (BABY-PULSAR)
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
연구 개요
상세 설명
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Elisa Coassin, MD
- 전화번호: +39 0434 659632
- 이메일: ecoassin@cro.it
연구 장소
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Pordenone
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Aviano, Pordenone, 이탈리아, 33081
- 모병
- Centro di Riferimento Oncolgico -IRCCS
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연락하다:
- Elisa Coassin
- 전화번호: 0434659632
- 이메일: ecoassin@cro.it
-
수석 연구원:
- Elisa Coassin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Radiological and/or histological diagnosis of diffuse midline glioma (DMG).
- Ability to maintain the treatment position or undergo sedation, if required.
- Written informed consent provided by the parent(s) or legal guardian(s), or by the patient if aged ≥18 years.
Exclusion Criteria:
- Refusal to undergo radiotherapy (i.e., lack of signed informed consent).
- Concurrent chemotherapy.
- Leptomeningeal dissemination of disease.
- Ongoing pregnancy (for post-pubertal female patients).
- Previous radiotherapy to the brainstem.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
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The radiotherapy treatment will preferably be delivered using volumetric modulated arc therapy (VMAT) with high-energy photons (6 MV), including 6 MV flattening filter-free (FFF) beams when appropriate. In selected cases, intensity-modulated radiotherapy (IMRT) may be used. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
기간: Up to 5 years
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Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale |
Up to 5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To evaluate the median time to local disease progression.
기간: Up to 5 years
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Median progression-free survival (PFS) defined as the time from treatment initiation to the first documented disease progression or death from any cause. Disease progression will be defined according to the RAPNO criteria for pediatric patients and the RANO criteria for adult patients. |
Up to 5 years
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To evaluate median overall survival.
기간: Up to 5 years
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Median overall survival (OS), defined as the time from treatment initiation to death from any cause. |
Up to 5 years
|
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To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
기간: Up to 5 years
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Frequency of neurological toxicities |
Up to 5 years
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To assess changes in neurological symptoms compared with baseline.
기간: Up to 5 years
|
Change in frequencies of neurological symptoms |
Up to 5 years
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To evaluate corticosteroid use during radiotherapy.
기간: Up to 5 years
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Dexamethasone dose (mg/day) mean |
Up to 5 years
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To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
기간: Up to 5 years
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Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method |
Up to 5 years
|
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To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
기간: Up to 5 years
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Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method |
Up to 5 years
|
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To evaluate tissue biomarkers of response to pLDRT.
기간: Up to 5 years
|
Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method |
Up to 5 years
|
|
To evaluate tissue biomarkers of response to pLDRT.
기간: Up to 5 years
|
Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method |
Up to 5 years
|
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To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule.
기간: Up to 5 years
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Mean of median levels of biomarkers of inflammatory and immune profile |
Up to 5 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CRO-2025-21
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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