Study on Early Temozolomide Treatment for Adults with Glioblastoma

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Centr Georges Francois Leclerc	Dijon	France
Aix Marseille University	Marseille	France
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre Henri Becquerel	Rouen	France
Grenoble Hospital Center	La Tronche	France
Centre Hospitalier Universitaire De Nice	Nice	France
Hospices Civils De Lyon	Lyon	France
Hopital NOVO	Pontoise	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Centre Francois Baclesse	Caen	France
Centre Hospitalier Pasteur	Colmar	France
Cahedr Hytxfqtbrfy Udmkmvvtaamsf Awgkvf Pnrikrip	Amiens	France
Ignuwrsf Rfioizph Dr Cvbrso Do Mxqwynmtusy	Montpellier	France
Cbhvyx Hpzczswlndx Es Uripcaidzpyyp De Lwlmphw	Limoges	France
Ckhe Dn Nepdh	Vandoeuvre Les Nancy	France
Cpnofz Lyrm Bpyzba	Lyon	France
Usinvbwvlg Hozsnnavz Pstcj Shpjlhjtzei Cvygpqi Fgln	Paris	France
Iykgvsin dn Cbklbtehuepd Hgqualtccxa Urnkqnwxdrqgd ds Smffg Eacsojy (fllwzdm	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.03.2019
France	Not recruiting	01.03.2019

Trial locations

Investigated drugs:

Temozolomide

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.

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 ID:

2022-500451-23-00

Protocol code:

StrateGlio-1802

NCT ID:

NCT03663725

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Early Temozolomide Treatment for Adults with Glioblastoma

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