Study on Glioblastoma Recurrence: Comparing SonoCloud-9 with Carboplatin to Standard Treatments Lomustine or Temozolomide for Patients Undergoing Tumor Removal Surgery

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What is this study about?

This clinical trial is focused on studying treatments for glioblastoma, a type of brain cancer that has returned after initial treatment. The study involves two different approaches. One group of patients will receive a combination of a device called SonoCloud-9 and a chemotherapy drug named carboplatin. The SonoCloud-9 device is used to help the chemotherapy reach the brain more effectively. The other group will receive standard chemotherapy treatments, which may include either lomustine or temozolomide, based on the doctor’s recommendation.

The purpose of the study is to compare the effectiveness of these treatments in improving the survival of patients with recurrent glioblastoma. Participants will undergo surgery to remove as much of the tumor as possible, followed by their assigned treatment. The study will monitor patients over a period of time to assess their overall survival and the progression of the disease. Patients will also be asked to report on their quality of life during the study.

Throughout the study, patients will receive regular check-ups and imaging tests, such as MRI scans, to track the size and growth of the tumor. The study aims to provide valuable information on which treatment approach may offer better outcomes for patients with this challenging condition. Participation in the study will involve regular visits to the clinic and adherence to the treatment plan as determined by the study protocol.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the experimental treatment or the standard treatment.

2 surgical procedure

The patient will undergo a planned surgical procedure to remove part of the tumor. This is known as resection and is a common approach for treating glioblastoma.

3 treatment group assignment

If assigned to the experimental group, the patient will receive a device called SonoCloud-9, which is used to open the blood-brain barrier. This is followed by chemotherapy with carboplatin, administered intravenously.

If assigned to the standard treatment group, the patient will receive either lomustine or temozolomide as determined by the physician. Both medications are taken orally.

4 chemotherapy administration

For the experimental group, carboplatin is given intravenously. The frequency and dosage will be determined by the healthcare provider based on individual patient needs.

For the standard treatment group, lomustine or temozolomide is taken orally. The specific dosage and schedule will be provided by the healthcare provider.

5 follow-up and monitoring

Regular follow-up visits will be scheduled to monitor the patient’s health and response to treatment. This includes imaging tests such as MRI to assess tumor size and progression.

The patient’s overall health, including blood tests and other assessments, will be monitored to manage any side effects from the treatment.

6 end of trial

The trial is expected to continue until November 2027. The patient’s participation will be concluded at the end of the trial or earlier if necessary based on health status or personal choice.

Who Can Join the Study?

The patient must have a confirmed diagnosis of glioblastoma, which is a type of brain tumor, and it must be the first time it has come back.
The patient must be able to understand the information about the clinical trial and be willing to sign a consent form to participate.
If the patient is a woman who can have children, she must have a negative pregnancy test within 14 days before joining the study and agree to use a reliable method of birth control during the treatment and for at least 1 month after the last cycle of the drug carboplatin if in the experimental group.
If the patient is a man, he must agree to use condoms during the treatment and for at least 3 months after the last cycle of carboplatin if in the experimental group, and he must not donate sperm during this time.
The patient must have health insurance that covers routine care costs and be part of a social security system, as required by the country.
The patient must have had previous treatment that included surgery or a biopsy and specific types of radiation therapy, as well as one type of maintenance therapy, which could include chemotherapy, immune therapy, or biological therapy.
The patient’s disease must have clearly gotten worse, with a measurable tumor size, and this must be confirmed by an MRI scan within 14 days before joining the study. There must be at least 12 weeks since the last radiation therapy unless there is a new tumor outside the treated area or clear evidence of a tumor from a sample.
The patient must be a candidate for a type of brain surgery called a craniotomy, and at least 50% of the tumor must be removable.
The largest part of the tumor must be 5 cm or smaller on a specific type of MRI scan before joining the study.
The patient must have a WHO performance status of 2 or less, which means they are able to carry out all self-care but are unable to carry out any work activities. They must be up and about more than 50% of waking hours.
The patient must be at least 18 years old.
The patient must have recovered from any immediate side effects of previous treatments.
The patient must have acceptable blood, liver, and kidney test results within 14 days before joining the study. This includes having enough red blood cells, platelets, and white blood cells, normal liver function tests, and good kidney function.

Who Cannot Join the Study?

Patients who have not experienced a first recurrence of glioblastoma. This means the glioblastoma must have come back for the first time after initial treatment.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are not able to undergo surgical procedures. The study involves surgery as part of the treatment.
Patients who cannot receive the specific types of chemotherapy used in the study. This includes treatments like carboplatin, lomustine, or temozolomide.
Patients who are part of a vulnerable population that the study does not include. This could mean groups that need special protection or consideration.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Hospital Foch	Suresnes	France
Virgen del Rocío University Hospital	Sevilla	Spain
Odense University Hospital	Odense	Denmark
Hospital Clinic De Barcelona	Barcelona	Spain
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Assistance Publique Hopitaux De Paris	Paris	France
Hospices Civils De Lyon	Lyon	France
Medical Center Haaglanden	Leidschendam	The Netherlands
Rigshospitalet	Copenhagen	Denmark
Centre hospitalier universitaire de Liege	Liege	Belgium
Charite Research Organisation GmbH	Berlin	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Vrije Universiteit Brussel	Jette	Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Awidgtz Unfvu Spegeoylx Ljfosk Dv Bziyzqq	Bologna	Italy
Igyqou Iuriddub Fghzdwrnngvag Ojosilgootn	Rome	Italy
Abeqztw Ukv Tkvkice nwss oypzm	Leghorn	Italy
Umcpqkpqto Hdqfirgf Cmnqztk	Cologne	Germany
Anmovtjusv Pafgbeel Htbqzwmy Dr Muhqaqval	Marseille	France
Usskjag Ugavisbkyn Hnlzmwxr	Uppsala	Sweden
Eaoyvol Uhbuudfibskm Mgkqvkz Cxksdbc Rreodyaxf (wvaxvvc Mpu	Rotterdam	The Netherlands
Abvqjus Oijlzluvuoo Utmkgkoqmkvoi Cwlhclcmkqji Dhaxr Susdvk E Doead Solklzm Dk Tfzall	Turin	Italy
Uxaajtyanopirmveefcme Menzyngc Axo	Munster	Germany
Uamvlgswyx Mdadkln Cswflq Hfkffepijomokvuzq	Hamburg	Germany
Ubriccwryuyhwaaqysvpr Efrvy Aek	Essen	Germany
Hwptqdbd Vpne dhosobiw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	15.09.2023
Belgium	Not recruiting	15.09.2023
Denmark	Not recruiting	15.09.2023
France	Not recruiting	15.09.2023
Germany	Not recruiting	15.09.2023
Italy	Not recruiting	15.09.2023
Spain	Not recruiting	15.09.2023
Sweden	Recruiting	15.09.2023
The Netherlands	Not recruiting	15.09.2023

Trial locations

Investigated drugs:

SonoCloud-9 is a device used in this trial to help open the blood-brain barrier. This allows medications to reach the brain more effectively. It is used in combination with chemotherapy to treat glioblastoma, a type of brain cancer.

Carboplatin is a chemotherapy medication used to treat various types of cancer. In this trial, it is used alongside the SonoCloud-9 device to treat patients with glioblastoma. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing.

Lomustine is a chemotherapy drug used as a standard treatment for brain tumors, including glioblastoma. It works by damaging the DNA of cancer cells, which stops them from multiplying.

Temozolomide is another chemotherapy medication used to treat brain cancers like glioblastoma. It works by damaging the DNA in cancer cells, which helps to stop their growth and spread.

Investigated diseases:

Glioblastoma

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth, often leading to increased pressure within the skull. The disease typically presents with symptoms such as headaches, nausea, seizures, and neurological deficits depending on the tumor’s location. Glioblastoma can recur after initial treatment, which is referred to as a recurrence. The first recurrence of glioblastoma involves the return of the tumor after it has been previously treated. This recurrence can lead to further complications and requires additional medical intervention.

Trial ID:

2023-505829-14-00

Protocol code:

SC9-GBM-03

NCT ID:

NCT05902169

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Glioblastoma Recurrence: Comparing SonoCloud-9 with Carboplatin to Standard Treatments Lomustine or Temozolomide for Patients Undergoing Tumor Removal Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?