Initial Radiological Diagnosis Eligible for Tumor ResectionPhase 2SonoFIRSTNCT04614493
Innovative SonoCloud-9 Device for Blood Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients.
A Phase 2 study testing SonoCloud-9 (SC9) device and Temozolomide according Stupp protocol in people with Initial Radiological Diagnosis Eligible for Tumor Resection and Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), run by Assistance Publique - Hôpitaux de Paris at 7 sites in 3 countries.
Trial summary
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve the prognosis of patients to date. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Initial Radiological Diagnosis Eligible for Tumor Resection, Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), Eligible for the Standard of Care Including Concurrent Temoradiation and Adjuvant Temozolomide
- What is being tested?
- SonoCloud-9 (SC9) device and Temozolomide according Stupp protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 11 Sep 2021to Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years , able and willing to give signed and informed consent. Inclusion for patients aged >70 years should be validated in neuro-oncology tumor board (RCP)
- MRI with suspicion of GBM or Patient with a newly histologically proven IDHwt GBM by previous stereotaxic biopsy or king size opened biopsy
- Karnofsky Performance Status ≥ 70
- Patient eligible for a total or sub-total surgical tumor resection
- Maximal tumor enhancement diameter at inclusion (pre surgery) ≤ 70 mm in T1W MRI
- Patient eligible after surgery for the first line standard of care temoradiation and adjuvant TMZ (Stupp protocol, 54)
Show all 20Show fewer
- Patient with adequate organ and bone marrow function within 14 days prior to registration, as defined below:
- Hemoglobin ≥ 10.0 g/dL
- Leukocytes ≥ 3,000/L
- Absolute neutrophil count ≥ 1,500/L
- Platelets ≥ 100,000/L
- Total bilirubin < 1.5 x ULN
- AST(SGOT)/ALT(SPGT) ≤ 3 x institutional ULN
- Alkaline phosphatase (ALP) < 3 x ULN
- Normal creatine clearance ≥ 60 mL/minute.
- Prothrombin time and partial thromboplastin time within institutional limits.
- For women of childbearing potential, a negative pregnancy test before inclusion and a medically acceptable method of birth control used throughout the study are required. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 1 month after the end of study visit
- A male patient must agree to use contraception as detailed in this Protocol during the treatment period and for at least 6 months after the last cycle of TMZ; he must refrain from donating sperm during this period
- Patient capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol
- Patient must be a beneficiary of or affiliated with a social security scheme
Who cannot join
- Patients with multifocal tumor (unless all localized in a 70 mm diameter area accessible to ultrasound field) or located in posterior fossa tumor
- Patient with diffuse FLAIR abnormalities attributable to Gliomatosis
- Patients with evidence of uncontrolled intracranial pressure
- Patients with uncontrolled epilepsy
- Patients with medical need to continue antiplatelet or antithrombotic treatment
- Pregnant or breastfeeding women (blood pregnancy test)
Show all 30Show fewer
- Patients with contra-indications to MRI or known sensitivity/allergy to gadolinium, or other intravascular contrast agents
- Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Luminity®/Definity®
- Patients with known intracranial aneurism, with and/or unremovable coils, clips, shunts, intravascular stents, wafer, non resorbable dura substitute, or reservoirs
- Patients with an uncontrolled intercurrent illness or any pre-existing comorbidities that in the Investigator's opinion may prevent the implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud or may be cofounding for evaluation of the clinical trial.
- Patients with the following are not eligible:
- Known arterial hypertension grade 3 or higher without adequate control on medications
- Known or suspected unstable active or chronic infections requiring systemic treatment
- Known significant cardiac disease: right-to-left shunts, Unstable angina pectoris, Symptomatic congestive heart failure, Unstable cardiac arrhythmia
- Known significant pulmonary disease: severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, adult respiratory distress syndrome, or Pneumonitis
- Known Severe renal failure
- Known serious myelosuppression
- Known Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Known immunodeficiency disease or treatments (HIV)
- Known viral or bacterial chronic/acute disease (potential blood borne infections that could result in meningitis or brain abscess)
- Patients under judicial protection
- Patients with any following prohibited treatments:
- Any investigational medicinal product within 30 days prior to inclusion and during the study
- Antibiotics with known neurotoxicity (eg, aminoglycosides, cephalosporin, quinolones), unless substitution is not possible,
- Non-absorbable material (dura matter substitute, hemostatic agent…)
- Any other drug according investigator to cause cerebral toxicity due to BBB opening
- Contra-indications to temozolomide
- Dacarbazine hypersensitivity
- Implantation of the SC-9 not possible according to neurosurgeon (any patient morphological characteristics (e.g. skin thin thickness >9mm), which, from neurosurgeons' opinion, prevent implantation of the device or may impair the ability of the patient to receive treatment with SonoCloud, would be excluded)
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
France5 sites, 5 recruiting
- Recruiting
Centre hospitalier Universitaire d'Angers
Angers, 49000
Philippe MENEI, MD, PhD, 33 2 41 35 48 22
- Recruiting
Groupe Hospitalier Saint-André
Bordeaux, 33000
Charlotte BRONNIMANN, MD, 33 5 57 82 17 37
- Recruiting
Hospices Civils de Lyon, Hôpital Pierre Wertheimer
Bron, 60900
François DUCRAY, MD, PhD, 33 4 72 35 78 06
- Recruiting
AP-HM, La Timone, Hôpital Universitaire
Marseille, 13000
Olivier CHINOT, MD, PhD, 33 4 91 38 65 69
- Recruiting
APHP-Sorbonne, Pitié Salpêtrière Hospital
Paris, 75013
Ahmed IDBAIH, MD, PhD, 33 1 42 16 03 85, ahmed.idbaih@aphp.fr
Alexandre CARPENTIER, MD, PhD, 33 1 42 16 34 05, alexandre.carpentier@aphp.fr
Belgium1 site, 1 recruiting
- Recruiting
Katholieke Universiteit Leuven
Leuven, 3000
Steve DE VLEESCHOUWER, MD, PhD, 32 16 3 44290
Switzerland1 site, 1 recruiting
- Not yet recruiting
Centre hospitalier universitaire vaudois CHUV
Lausanne, CH-1011
Andreas HOTTINGER, MD, PhD, 41 21 314 6541
About this study
Official title: Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening.
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve the prognosis of patients to date. One of the main reasons is the presence of blood brain barrier (BBB) which limits therapeutic agents uptake in the brain. GBM is also considered to have a "cold" (unresponsive) immunological microenvironment due to factors released by the tumor and the presence of BBB limiting the transit of immune cells from the systemic circulation. Therefore, by-passing the BBB appears as a promising strategy.
The objective of the Phase II clinical trial, SonoFIRST, is to evaluate if the use of therapeutic ultrasound device, sonoCloud-9 (SC9) could improve the progression free survival of newly diagnosed GBM patients, treated by concurrent temoradiation and adjuvant temozolomide. The transient opening of the BBB by ultrasound with the SonoCloud-9 (SC9) device, predicts the increase in the penetration of temozolomide (TMZ) into the brain and the stimulation of cerebral immunity with the prospect of improving the survival of 160,000 new brain tumor patients each year in Europe and the United States.
Read the detailed description
This will be an open-label, Phase 2, multicenter, double arm, randomized, interventional trial that will evaluate primarily the clinical efficacy of the device and will be to compare Progression Free Survival (PFS) between the standard of care treatment with concomitant ultrasound BBB opening versus standard of care alone. Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Currently, prognosis is very poor, with a survival of about 15 months with current therapies. Although intensive treatments combining surgery, radiotherapy and chemotherapy, the prognosis of GBM patients remains poor. New treatment strategies are urgently needed.
In the brain, the presence of the blood-brain barrier (BBB) limits the uptake of therapeutic agents. To encounter this BBB issue, Professor Alexandre Carpentier and his team developed an ultrasound medical device (SonoCloud), implanted in the skull during surgery. This highly innovative technique temporarily permeates the BBB, increasing drug delivery to the brain by five times. The SonoCloud, a low-intensity pulsed ultrasound device developed by CarThera, is one of the major innovations in this field, as shown by the encouraging results obtained in studies in recurrent GBM.
The expected benefits of using the SonoCloud-9 experimental device prior to TMZ chemotherapy are the stabilization or reduction of GBM tumor volume on the one hand, and stabilization or improvement of the patient's neurological status on the other hand.
Participation in the clinical trial will contribute to a better understanding of the safety and efficacy of opening the BBB. It will be possible to determine whether the BBB opening using low-intensity pulsed ultrasound can be effective in treating GBM, in addition to the standard of care protocol.
- Conditions
- Initial Radiological Diagnosis Eligible for Tumor Resection, Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), Eligible for the Standard of Care Including Concurrent Temoradiation and Adjuvant Temozolomide
- Being tested
- SonoCloud-9 (SC9) device, Temozolomide according Stupp protocol
- Keywords
- Primary brain cancer, Glioblastoma, first line, Stupp protocol, Ultrasounds, Medical device, SC9
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoCloud-9 (SC9) deviceDevice
daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months) with 6 concomitant Blood Brain Barrier opening sessions by ultrasound
+ 9 Blood Brain Barrier opening sessions by ultrasound without any associated drug
Temozolomide according Stupp protocolDrug
daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months)
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound experimental arm | Experimental | Standard of Care + 15 Ultrasound BBB opening Receives: Device: SonoCloud-9 (SC9) device; Drug: Temozolomide according Stupp protocol |
| Control arm | Other | Standard of Care Receives: Drug: Temozolomide according Stupp protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS), PFS is defined as the time between randomization and disease progression which is the first documented tumor progression (per local Investigator assessment according to the RANO criteria) or death due to any cause.
Progression will be assessed by local investigator according to the RANO criteria
Measured: Between randomisation and 18 months after the last inclusion.
Secondary outcomes (10)
Overall Survival improvement (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: Between randomisation and 18 months after the last inclusion.
central review Progression Free Survival (crPFS)
The central review Progression Free Survival is evaluated by a central assessment (independent imaging core lab) at the end of study and is defined as the time between randomization and tumor progression which is the first documented tumor progression according to the radiological RANO criteria or death due to any cause
Measured: Between randomisation and 18 months after the last inclusion.
immune Progression Free Survival (iPFS)
The iPFS is evaluated according to iRANO (immune-related modifications / pseudo-progression ) criteria assessed by local investigator
Measured: Between randomisation and 18 months after the last inclusion.
Mean score of Patient quality of life preservation - EORTC Quality of Life Questionnaire C30
Quality of Life Questionnaire (QLQ) according to the European Organization for Research and Treatment of Cancer will be assessed by mean scores of the EORTC QLQ C-30 questionnaire (30 questions, score from 30 to 126) by local investigator or nurses and patient
Measured: Before surgery, pre-TemoRadiation visit, Cycle 1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11 and Month 18, or until progression up to 18 months
Mean score Patient quality of life preservation - BN20 Quality of Life Questionnaire
Quality of Life Questionnaire (QLQ) according to the European Organization for Research and Treatment of Cancer will be assessed will be assessed by means of the EORTC BN20 questionnaire (30 questions, score from 1 to 80) by local investigator or nurses and patient
Measured: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Karnofsky Performance Status (KPS)
Measured: Before surgery, Surgery (+/- device implantation), pre-TemoRadiation visit, start and day 15 of each cycle (=28 days) from Cycle 1 to 6, Month 11, Month 13, Month 15, or until progression up to 18 months, new surgery (debulking or device explantation)
Mean score of Patient cognitive preservation
Mini Mental Status Examination (30-point questionnaire, score from 1 to 30) mean score assessed by local investigator or nurses and patient
Measured: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Visual analogic scale (VAS) Pain score from surgical area
pain score from surgical area using visual analogic scale (score 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible).
Measured: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Esthetical
score in self-confidence concerning esthetical dimension of surgical scar using esthetical comfort question equivalent to q39 of QLQ-BR23 questionnaire: Does your skull scar induce any esthetic burden to you?
- Not at all
- A little
- Quite a bit
- Very much
Measured: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Safety : Type, frequency and severity of adverse events and serious adverse events
Safety confirmation of efficient blood brain barrier opening procedure with the SonoCloud-9 system. Safety confirmation is assessed by the frequency and severity of Adverse Events (AE) (incidence of AE summarized by system organ class and/or preferred term and severity) based on the Common Terminology Criteria for Adverse Events, version 5.0.
Measured: From inclusion to end of treatment, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start11 Sep 2021
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Initial Radiological Diagnosis Eligible for Tumor ResectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed IDBAIH, MD, PhD, Principal investigator, APHP-Sorbonne, Pitie Salpetriere Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614493
- Sponsor's protocol ID
- APHP200080
- Other IDs
- 2020-001488-10
- Acronym
- SonoFIRST
- Status last verified
- Mar 2022
- First submitted
- 21 Oct 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.
PubMed 27306666Idbaih A, Canney M, Belin L, Desseaux C, Vignot A, Bouchoux G, Asquier N, Law-Ye B, Leclercq D, Bissery A, De Rycke Y, Trosch C, Capelle L, Sanson M, Hoang-Xuan K, Dehais C, Houillier C, Laigle-Donadey F, Mathon B, Andre A, Lafon C, Chapelon JY, Delattre JY, Carpentier A. Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Clin Cancer Res. 2019 Jul 1;25(13):3793-3801. doi: 10.1158/1078-0432.CCR-18-3643. Epub 2019 Mar 19.
PubMed 30890548
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening.
- ClinicalTrials.gov ID
- NCT04614493
- Acronym / sponsor ID
- SonoFIRST / APHP200080
- Conditions
- Initial Radiological Diagnosis Eligible for Tumor Resection, Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), Eligible for the Standard of Care Including Concurrent Temoradiation and Adjuvant Temozolomide
- Keywords
- Primary brain cancer, Glioblastoma, first line, Stupp protocol, Ultrasounds, Medical device, SC9
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve the prognosis of patients to date. One of the main reasons is the presence of blood brain barrier (BBB) which limits therapeutic agents uptake in the brain. GBM is also considered to have a "cold" (unresponsive) immunological microenvironment due to factors released by the tumor and the presence of BBB limiting the transit of immune cells from the systemic circulation. Therefore, by-passing the BBB appears as a promising strategy.
The objective of the Phase II clinical trial, SonoFIRST, is to evaluate if the use of therapeutic ultrasound device, sonoCloud-9 (SC9) could improve the progression free survival of newly diagnosed GBM patients, treated by concurrent temoradiation and adjuvant temozolomide. The transient opening of the BBB by ultrasound with the SonoCloud-9 (SC9) device, predicts the increase in the penetration of temozolomide (TMZ) into the brain and the stimulation of cerebral immunity with the prospect of improving the survival of 160,000 new brain tumor patients each year in Europe and the United States.
Detailed description
This will be an open-label, Phase 2, multicenter, double arm, randomized, interventional trial that will evaluate primarily the clinical efficacy of the device and will be to compare Progression Free Survival (PFS) between the standard of care treatment with concomitant ultrasound BBB opening versus standard of care alone. Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Currently, prognosis is very poor, with a survival of about 15 months with current therapies. Although intensive treatments combining surgery, radiotherapy and chemotherapy, the prognosis of GBM patients remains poor. New treatment strategies are urgently needed.
In the brain, the presence of the blood-brain barrier (BBB) limits the uptake of therapeutic agents. To encounter this BBB issue, Professor Alexandre Carpentier and his team developed an ultrasound medical device (SonoCloud), implanted in the skull during surgery. This highly innovative technique temporarily permeates the BBB, increasing drug delivery to the brain by five times. The SonoCloud, a low-intensity pulsed ultrasound device developed by CarThera, is one of the major innovations in this field, as shown by the encouraging results obtained in studies in recurrent GBM.
The expected benefits of using the SonoCloud-9 experimental device prior to TMZ chemotherapy are the stabilization or reduction of GBM tumor volume on the one hand, and stabilization or improvement of the patient's neurological status on the other hand.
Participation in the clinical trial will contribute to a better understanding of the safety and efficacy of opening the BBB. It will be possible to determine whether the BBB opening using low-intensity pulsed ultrasound can be effective in treating GBM, in addition to the standard of care protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound experimental arm | Experimental | Device: SonoCloud-9 (SC9) device, Drug: Temozolomide according Stupp protocolStandard of Care + 15 Ultrasound BBB opening |
| Control arm | Other | Drug: Temozolomide according Stupp protocolStandard of Care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years , able and willing to give signed and informed consent. Inclusion for patients aged >70 years should be validated in neuro-oncology tumor board (RCP)
- MRI with suspicion of GBM or Patient with a newly histologically proven IDHwt GBM by previous stereotaxic biopsy or king size opened biopsy
- Karnofsky Performance Status ≥ 70
- Patient eligible for a total or sub-total surgical tumor resection
- Maximal tumor enhancement diameter at inclusion (pre surgery) ≤ 70 mm in T1W MRI
Key exclusion criteria (30 listed)
- Patients with multifocal tumor (unless all localized in a 70 mm diameter area accessible to ultrasound field) or located in posterior fossa tumor
- Patient with diffuse FLAIR abnormalities attributable to Gliomatosis
- Patients with evidence of uncontrolled intracranial pressure
- Patients with uncontrolled epilepsy
- Patients with medical need to continue antiplatelet or antithrombotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SonoCloud-9 (SC9) devicedaily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months) with 6 concomitant Blood Brain Barrier opening sessions by ultrasound + 9 Blood Brain Barrier opening sessions by ultrasound without any associated drug | Device | Ultrasound experimental arm |
| Temozolomide according Stupp protocoldaily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months) | Drug | Control arm, Ultrasound experimental arm |
Primary outcome
Progression Free Survival (PFS), PFS is defined as the time between randomization and disease progression which is the first documented tumor progression (per local Investigator assessment according to the RANO criteria) or death due to any cause.
Time frame: Between randomisation and 18 months after the last inclusion.
Progression will be assessed by local investigator according to the RANO criteria
10 secondary outcomes
Overall Survival improvement (OS)
Time frame: Between randomisation and 18 months after the last inclusion.
central review Progression Free Survival (crPFS)
Time frame: Between randomisation and 18 months after the last inclusion.
immune Progression Free Survival (iPFS)
Time frame: Between randomisation and 18 months after the last inclusion.
Mean score of Patient quality of life preservation - EORTC Quality of Life Questionnaire C30
Time frame: Before surgery, pre-TemoRadiation visit, Cycle 1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11 and Month 18, or until progression up to 18 months
Mean score Patient quality of life preservation - BN20 Quality of Life Questionnaire
Time frame: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Karnofsky Performance Status (KPS)
Time frame: Before surgery, Surgery (+/- device implantation), pre-TemoRadiation visit, start and day 15 of each cycle (=28 days) from Cycle 1 to 6, Month 11, Month 13, Month 15, or until progression up to 18 months, new surgery (debulking or device explantation)
Mean score of Patient cognitive preservation
Time frame: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Visual analogic scale (VAS) Pain score from surgical area
Time frame: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Esthetical
Time frame: Before surgery, pre-TemoRadiation visit, Cycle1 (baseline after surgery/radiotherapy, 1 cycle = 28 days), Cycle 3, Cycle 6, Month 11, Month 18, or until progression up to 18 months
Safety : Type, frequency and severity of adverse events and serious adverse events
Time frame: From inclusion to end of treatment, up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 27306666Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.
- Background: PubMed 30890548Idbaih A, Canney M, Belin L, Desseaux C, Vignot A, Bouchoux G, Asquier N, Law-Ye B, Leclercq D, Bissery A, De Rycke Y, Trosch C, Capelle L, Sanson M, Hoang-Xuan K, Dehais C, Houillier C, Laigle-Donadey F, Mathon B, Andre A, Lafon C, Chapelon JY, Delattre JY, Carpentier A. Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Clin Cancer Res. 2019 Jul 1;25(13):3793-3801. doi: 10.1158/1078-0432.CCR-18-3643. Epub 2019 Mar 19.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed IDBAIH, MD, PhD principal investigator
APHP-Sorbonne, Pitie Salpetriere Hospital, Paris
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SonoCloud-9 (SC9) device and Temozolomide according Stupp protocol in people with Initial Radiological Diagnosis Eligible for Tumor Resection and Initial Radiological Diagnosis Compatible With Newly Diagnosed Glioblastoma (IDH Wild-type), run by Assistance Publique - Hôpitaux de Paris at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed IDBAIH, MD, PhD (33 1 42 16 03 85, ahmed.idbaih@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS), PFS is defined as the time between randomization and disease progression which is the first documented tumor progression (per local Investigator assessment according to the RANO criteria) or death due to any cause. (time frame: Between randomisation and 18 months after the last inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614493, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.