NL-OMON56543尚未招募3 期
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma - SONOBIRD
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Carthera
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically proven glioblastoma (WHO criteria 2021), absence of IDH
- •mutation demonstrated by negative IDH1 R132H staining on IHC. 2. Patient must
- •have received prior first line therapy that must have contained both: a) Prior
- •surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy/fraction,
- •>56 Gy<66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy or similar
- •regimen) b) One line of maintenance chemotherapy and/or immune- or biological
- •therapy, (with or without TTFields) 3. First, unequivocal disease progression
- •with a) measurable tumor (>100 mm2 or 1 cm3, based on RANO criteria) documented
- •(e.g., increase of 25% in tumor diameter) on MRI performed within 14 days of
- •inclusion and, b) interval of a minimum of 12 weeks since the completion of
- •prior radiotherapy, unless there is a new lesion outside the radiation field or
- •unequivocal evidence of viable tumor on histopathological sampling 4. Patient
- •is candidate for craniotomy and at least 50% resection of enhancing region 5.
- •Maximal enhancing tumor diameter prior to inclusion <= 5 cm on T1w. (In case of
- •planned lobectomy, post operative peritumoral brain or residual size <=5 cm) 6.
- •WHO performance status <= 2 (equivalent to Karnofsky Performance Status, KPS >=
- •70) 7. Age >= 18 years 8. Participant must be recovered from acute toxic effects
排除标准
- •1. Multifocal enhancing tumor on T1w (unless all localized in a 5 cm diameter
- •2. Posterior fossa tumor
- •3. Known BRAF/ NTKR mutated patients
- •4. Patient at risk of surgery site infection (e.g., 2 or more previous
- •craniotomies/neurosurgery within the last 3 months, poor skin condition, and/or
- •previously infected surgical field, or any other condition that is of increased
- •infectious risk in the opinion of the neurosurgeon)
- •5. Patient treated at high, stable -or average- dose of corticosteroids (>= 6
- •mg/day dexamethasone or equivalent) in the 7 days prior to inclusion. Patients
- •on dexamethasone for reasons other than mass effect may still be enrolled.
- •6. Contra-indication to carboplatin, CCNU or TMZ
- •7. Known history of hypersensitivity reactions to perflutren lipid microsphere
- •components or to any of the inactive ingredients in ultrasound resonator
- •8. Patient has received bevacizumab for other reasons (such as tumor
- •progression) than treating edema
- •9. Peripheral neuropathy or neuropathy >= grade 2
- •10. Uncontrolled epilepsy or evidence of intracranial pressure
- •11. Patient with known intracranial aneurism or having presented intra-tumor
- •significant spontaneous hemorrhage
- •12. Patient with unremovable coils, clips, shunts, intravascular stents, and/or
- •wafer, or reservoirs
- •13. Patient with medical need to be on continued anti-platelet aggregation
- •therapy and/or anticoagulation. Patients for whom anticoagulation/platelet
- •aggregation can be temporarily interrupted may be eligible after discussion and
- •prior authorization by the sponsor.
- •14. Patient receiving enzyme-inducing antiepileptic drugs (namely phenytoin,
- •carbamazepine and derivatives, phenobarbital), unless switched on another
- •antiepileptic regimen
- •15. History of other malignancy within 3 years prior to study start with the
- •exception of adequately treated basal cell carcinoma, squamous cell carcinoma,
- •non-melanomatous skin cancer or carcinoma in situ of the uterine cervix
- •16. Patient with known or suspected active or chronic infections
- •17. Patient with known significant cardiac disease, known to have right-to-left
- •shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mm Hg),
- •uncontrolled systemic hypertension, or acute respiratory distress syndrome
- •18. Known sensitivity/allergy to gadolinium, or other intravascular contrast
- •19. Patient with impaired thermo-regulation or temperature sensation
- •20. Pregnant, or breastfeeding patient
- •21. Any other serious patient medical or psychological condition that may
- •interfere with adequate and safe delivery of treatment and care (e.g., positive
- •human immunodeficiency virus [HIV] status, potential blood-borne infections,*),
- •circumstance (e.g., sinus opening during surgery), psychological, morphological
- •characteristics (e.g., skin characteristics, bone thickness), or any
- •pre-existing comorbidities that in the investigator*s opinion may prevent the
- •implantation of the device, may impair the ability of the patient to receive
- •treatment with SonoCloud-9 or may be confounding for evaluation of the clinical
- •trial endpoints
- •22. Patients under guardianship, curatorship, under legal protection or
- •deprived of liberty by an administrative or judicial decision
研究者
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