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Study on Glioblastoma Treatment with Temozolomide, Lomustine, and Perflutren for Newly Diagnosed Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of brain cancer called glioblastoma, which is a fast-growing and aggressive tumor. The study is investigating the effects of a treatment that combines standard care with a new approach involving ultrasound to help open the blood-brain barrier. This barrier is a protective shield around the brain that can make it difficult for treatments to reach the tumor. The trial will compare the usual treatment with and without this ultrasound technique to see if it helps improve patient outcomes.

The treatment being studied includes the use of temozolomide, a chemotherapy drug, and may also involve lomustine, another chemotherapy medication. Additionally, a special gas called perflutren is used to help with the ultrasound process. Some patients will receive a placebo instead of the ultrasound treatment to help researchers understand the true effects of the ultrasound. The purpose of the study is to determine if the ultrasound method can improve the time patients live without the disease getting worse, known as progression-free survival.

Participants in the study will undergo a series of treatments and assessments over a period of time. This includes regular check-ups and imaging tests like MRI to monitor the tumor's response to the treatment. The study aims to provide valuable information on whether this new approach can offer better outcomes for patients with newly diagnosed glioblastoma. The trial will continue until enough data is collected to make a clear comparison between the different treatment methods.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the clinical trial, you will be informed about the study's purpose and procedures. You will be required to provide signed and informed consent, confirming your willingness to participate.

  2. Step 2

    Initial assessments

    You will undergo a brain MRI to confirm the diagnosis of newly diagnosed glioblastoma. This step ensures that the tumor is suitable for the trial's treatment plan.

    Your overall health and ability to participate will be evaluated using the Karnofsky Performance Status (KPS), which measures your ability to perform everyday activities.

  3. Step 3

    Surgery and baseline assessments

    If eligible, you will undergo surgery to remove part or all of the tumor. This is a standard procedure for glioblastoma treatment.

    After surgery, baseline assessments will be conducted, including the Mini Mental Status Examination (MMSE) to evaluate cognitive function, and quality of life questionnaires (QLQ-C30 and QLQ-BN20PROM) to assess your well-being.

  4. Step 4

    Temoradiation treatment

    You will receive concurrent temoradiation, which combines the chemotherapy drug temozolomide with radiation therapy. This phase follows the Stupp protocol, a standard treatment for glioblastoma.

    The treatment involves taking temozolomide orally, with the dosage and frequency determined by your healthcare provider.

  5. Step 5

    Adjuvant therapy

    After completing the initial treatment, you will continue with adjuvant therapy, which involves taking temozolomide to help prevent the tumor from returning.

    This phase may also include the use of ultrasound to open the blood-brain barrier, depending on your treatment group.

  6. Step 6

    Follow-up assessments

    Throughout the trial, regular follow-up assessments will be conducted to monitor your health and the effectiveness of the treatment.

    These assessments include repeated MMSE, quality of life questionnaires, and evaluations of any side effects or adverse events.

  7. Step 7

    End of trial

    The trial will conclude once the study objectives are met or if you decide to withdraw from the study.

    Your overall survival and progression-free survival will be evaluated to determine the treatment's effectiveness.

Who can join the trial?

6 criteria

  • Patients must have a brain MRI showing suspicion of a newly diagnosed **IDH wild-type Glioblastoma**. This is a specific type of brain tumor.
  • The tumor must be located in the **supratentorial** region of the brain, which is the upper part of the brain.
  • The tumor must show enhancement on a T1-weighted MRI scan and be **7 cm or smaller** in size.
  • Patients must be eligible for either partial or complete surgical removal of the tumor and for treatment with **TemoRadiation** followed by **adjuvant TMZ**. This is a standard treatment protocol for this condition.
  • Patients must be **18 years or older** and able and willing to provide signed and informed consent. For patients older than 70 years, inclusion must be validated by a neuro-oncology tumor board.
  • Patients must have a **Karnofsky Performance Status (KPS) of 70 or higher**. This is a scale that measures the patient's ability to perform everyday activities, with 100 being fully active and 0 being deceased.

Who cannot join the trial?

4 criteria

  • Patients who have not been newly diagnosed with **Glioblastoma** (a type of brain tumor).
  • Patients who are not eligible for **tumor resection** (surgery to remove the tumor).
  • Patients who cannot receive the **standard of care**, which includes **temoradiation** (a combination of chemotherapy and radiation therapy) followed by **adjuvant TMZ** (a type of chemotherapy).
  • Patients who are not eligible for **Tumor Treating Fields** (a treatment that uses electric fields to disrupt cancer cell division) if they are in centers where this treatment is not available.
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Investigated drugs

  • Temozolomide

    is a medication used in this clinical trial to treat glioblastoma, which is a type of brain cancer. It works by damaging the DNA of cancer cells, which can help to stop them from growing and spreading. In this trial, temozolomide is used alongside radiation therapy to see if it can improve the treatment outcomes for patients with newly diagnosed glioblastoma.

  • Ultrasound-induced blood-brain barrier opening

    is a therapy being tested in this trial. The blood-brain barrier is a protective layer that prevents harmful substances from entering the brain. However, it can also block helpful treatments from reaching brain tumors. This therapy uses ultrasound waves to temporarily open the blood-brain barrier, allowing medications like temozolomide to enter the brain more effectively and potentially improve treatment results.

What is already known about the treatment

Temozolomide – Temozolomide is administered orally in the form of capsules and is used in the treatment of newly diagnosed glioblastoma, a type of brain cancer. It is currently well-established in medical practice and literature as a standard treatment for this condition, often used alongside radiation therapy. The main therapeutic indication for temozolomide is to slow the progression of glioblastoma by damaging the DNA of cancer cells, which prevents them from dividing and growing. It belongs to the pharmacological class of alkylating agents, which work by adding an alkyl group to the DNA, leading to cell death.

Investigated diseases

Glioblastoma (IDH wild-type) – Glioblastoma is an aggressive type of brain tumor that originates from glial cells. It is characterized by rapid growth and a tendency to infiltrate surrounding brain tissue, making it difficult to remove completely through surgery. The disease often presents with symptoms such as headaches, seizures, and neurological deficits, depending on the tumor's location in the brain. As the tumor progresses, it can cause increased intracranial pressure and further neurological impairment. Glioblastoma is known for its heterogeneity, meaning the tumor cells can vary significantly within the same tumor, contributing to its aggressive nature. The progression of glioblastoma is typically marked by a rapid increase in tumor size and worsening of symptoms over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511880-27-00Protocol codeAPHP200080Estimated enrolment63 patientsSponsorAssistance Publique Hopitaux De Paris

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