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Study on Early Temozolomide Treatment for Adults with Glioblastoma

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 form of cancer that occurs in the brain. The study is testing a treatment using a medication called temozolomide. Temozolomide is a type of chemotherapy drug that is taken by mouth and works by slowing or stopping the growth of cancer cells. The purpose of the study is to evaluate whether starting treatment with temozolomide earlier than usual can improve the overall survival of adults diagnosed with glioblastoma.

Participants in the study will be randomly assigned to receive either the early treatment with temozolomide or the standard treatment protocol. The study will begin treatment within 15 days after surgery or biopsy, which is earlier than the usual start time. The treatment will continue for a maximum period of 10 months. Throughout the study, participants will be monitored for their overall health and any side effects they may experience. The study aims to understand if the early use of temozolomide can lead to better outcomes for patients with glioblastoma.

Overall survival, which is the time from the start of the study until death from any cause, will be the main focus of the study. Additionally, the study will look at other factors such as the time until the disease progresses and the quality of life without symptoms or side effects. The study will also collect information on any adverse events, which are unwanted effects that may occur during the treatment. This information will help researchers understand the potential benefits and risks of starting temozolomide treatment earlier in patients with glioblastoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent. Eligibility is confirmed based on criteria such as age, medical condition, and biological functions.

    The patient must have a histological diagnosis of a new glioblastoma and meet specific health criteria, including adequate blood cell counts and organ function.

  2. Step 2

    Initial treatment phase

    The patient begins treatment with temozolomide, an oral medication. The dosage and frequency are determined by the study protocol.

    This phase involves early treatment intensification with temozolomide, which is compared to the standard treatment protocol.

  3. Step 3

    Radiation therapy

    Standard radiation therapy is administered, consisting of 60 Gy delivered in 30 fractions.

    The time interval between initial surgery or biopsy and the start of radiation therapy must be less than 43 days.

  4. Step 4

    Monitoring and follow-up

    The patient's overall survival is monitored from the time of randomization until the end of the study or the patient's death.

    Adverse events are recorded and graded according to severity. The study also tracks progression-free survival and quality-adjusted time without symptoms or adverse events.

  5. Step 5

    Completion of study

    The study is estimated to end by May 2025. The patient will be informed of any post-progression treatments and their duration.

    The study aims to evaluate the impact of early treatment intensification with temozolomide on overall survival compared to the standard protocol.

Who can join the trial?

12 criteria

  • Patient must be **18 years or older**.
  • There should be a planned **MGMT analysis**. This is a test related to the tumor, but the results are not needed at the start of the study.
  • Patient must provide **written informed consent** or have a trusted person do so on their behalf.
  • Patient must be covered by the **French or Belgian Social Security** system if they are from France or Belgium.
  • Patient must have a **histological diagnosis** of a new glioblastoma. This means the tumor has been confirmed by examining tissue under a microscope. If the initial diagnosis is not confirmed, the patient will be removed from the study.
  • The time between the first surgery or biopsy and the planned start of treatment should be **14 days or less**, ideally within the first 7 days.
  • Patient must have a **Karnofsky performance status (KPS) of 60% or higher**. This is a scale that measures the patient's ability to perform daily activities. If the KPS is less than 60%, it should only be due to weakness caused by the tumor.
  • Patient must have **adequate biological functions**. This includes having enough white blood cells and platelets, normal kidney function, and liver function within acceptable limits.
  • Any side effects from previous treatments should be **mild (Grade 1 or less)**, except for hair loss, nausea, vomiting, and neurological symptoms.
  • Females who can have children must have a **negative pregnancy test** before starting treatment. All sexually active patients must agree to use **effective birth control** during the study and for 6 months after stopping the study drug.
  • **Standard radiation therapy** must be possible. This involves a specific dose and number of treatments.
  • The time between the first surgery or biopsy and the planned start of radiation therapy should be **less than 43 days**.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of brain tumor other than a de novo glioblastoma. A de novo glioblastoma is a specific kind of aggressive brain tumor that starts on its own, not from another type of tumor.
  • Patients who are not adults. This study is only for adults, meaning people who are 18 years or older.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medication might affect the baby.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
  • Patients who have had previous treatment for their glioblastoma, as this study is for those who have not been treated yet.
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Investigated drugs

Temozolomide: This medication is used in the trial to treat adults with glioblastoma, a type of brain cancer. The study is evaluating whether starting treatment with Temozolomide earlier can improve overall survival compared to the standard treatment protocol. Temozolomide works by slowing or stopping the growth of cancer cells.

What is already known about the treatment

Temozolomide – Temozolomide is administered orally in capsule form. It is currently being studied in clinical trials for its effectiveness in treating adults with newly diagnosed glioblastoma, a type of brain cancer. The medication is primarily used as a chemotherapy agent to slow or stop the growth of cancer cells. At the molecular level, Temozolomide works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as an alkylating agent in pharmacology.

Investigated diseases

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. As the tumor grows, it can invade surrounding brain tissue, making it difficult to remove completely. Glioblastoma is characterized by its tendency to recur even after treatment. The progression of the disease can vary, but it generally involves worsening neurological function and increased tumor size over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500451-23-00Protocol codeStrateGlio-1802Estimated enrolment460 patientsSponsorCentre Oscar Lambret

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