Study on Lomustine with or without Additional Brain Radiation for Patients with Recurrent Glioblastoma

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What is this study about?

This clinical trial is focused on studying the treatment of glioblastoma, a type of brain cancer. The study will use a medication called lomustine, which is a type of chemotherapy drug. The trial will explore the effects of using lomustine alone or in combination with a second round of brain radiation, known as reirradiation, to see if this combination can improve patient outcomes.

The purpose of the study is to determine if the combination of lomustine and reirradiation is more effective than using lomustine by itself for patients whose glioblastoma has returned after initial treatment. Participants in the study will be randomly assigned to receive either the combination treatment or lomustine alone. The study will monitor the participants over a period to assess their overall survival and other health outcomes.

Throughout the study, participants will undergo regular assessments to track the progress of their condition and any side effects they may experience. The trial aims to provide valuable information on whether adding reirradiation to lomustine treatment can offer better results for patients with recurrent glioblastoma.

1 enrollment

Upon joining the study, the patient must provide written informed consent. This is a formal agreement to participate, acknowledging understanding of the study’s purpose and procedures.

Women of childbearing potential must undergo a pregnancy test within 7 days before starting the treatment to ensure safety.

2 initial assessment

The patient will be assessed to confirm eligibility, including a review of medical history and current health status.

The patient must have a confirmed diagnosis of glioblastoma and meet specific health criteria, such as a stable or decreasing dose of steroids for 7 days prior to enrollment.

3 treatment allocation

The patient will be randomly assigned to one of two groups: one receiving lomustine alone, and the other receiving lomustine with additional brain radiation.

Lomustine is administered orally. The dosage and frequency will be determined by the study protocol and the patient’s specific needs.

4 treatment period

The patient will receive the assigned treatment over a specified period. The duration and schedule will be communicated by the study team.

Regular monitoring will occur to assess the patient’s response to treatment and any side effects. This includes physical exams and possibly imaging tests.

5 follow-up assessments

Throughout the study, the patient’s health and response to treatment will be evaluated using various criteria, such as the Response Assessment in Neuro Oncology (RANO) criteria.

The patient’s cognitive function and quality of life will also be assessed using standardized tests and questionnaires.

6 study completion

The study is expected to conclude by February 29, 2028. The patient will continue to be monitored until the end of the study period.

Final assessments will be conducted to evaluate the overall survival and progression of the disease.

Who Can Join the Study?

Before joining the study, the patient must provide written informed consent, which means they agree to participate after understanding the study details.
Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
The patient must be a candidate for treatment with a medication called lomustine, as determined by their doctor.
Patients who can have children must agree to use effective birth control during the study and for at least 6 months after the last dose of treatment. Effective birth control means methods that are very reliable when used correctly.
The patient must have a first progression or return of glioblastoma after initial treatment, which included a biopsy or surgery and standard radiotherapy or chemoradiotherapy, and this must have happened at least 6 months after the previous radiotherapy.
The patient must have a measurable disease according to RANO criteria, with a maximum tumor size of 5 cm, as assessed by the local investigator. If there are multiple tumors, the total size must be treatable by one treatment area.
If the patient had surgery for the return of the disease, they must be fully recovered from surgery, have confirmation of the disease return by examining tissue, and be fit for treatment as assessed by the local investigator.
The patient must have a confirmed diagnosis of glioblastoma, IDH wildtype, according to the WHO 2021 classification, based on tissue from the initial diagnosis or recurrence.
The patient must have a stable or decreasing dose of steroids for 7 days before joining the study.
The patient must be 18 years or older.
The patient must have a WHO Performance status of 0-2, which means they are fully active or have some limitations but can take care of themselves.

Who Cannot Join the Study?

Patients who are not experiencing their first progression of glioblastoma. Glioblastoma is a type of brain cancer.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Oslo Universitetssykehus HF	Oslo	Norway
Centre Jean Perrin	Clermont Ferrand	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
University Hospital Jena KöR	Jena	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Algemeen Stedelijk Ziekenhuis Campus Aalst	Aalst	Belgium

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Instituto Di Ricovero E Cura A Carattere Scientifico	Bologna	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
St. Olavs Hospital HF	Trondheim	Norway
Grand Hopital De Charleroi	Charleroi	Belgium
Ospedale Mater Salutis Di Legnago	Legnago	Italy
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Kepler Universitaetsklinikum GmbH	Linz	Austria
Gasthuiszusters Antwerpen	Antwerp	Belgium
Centre Hospitalier Universitaire De Nice	Nice	France
Region Midtjylland	Aarhus	Denmark
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Cxqkbkbbr Uokpcjwkvshgtx Sdspyypob	Woluwe-Saint-Lambert	Belgium
Uzqzxggyqiyydutjujytl Kewzxjbmworhmvbkxwccreo Bionem Geso	Bochum	Germany
Uwugrrsxwzftnounavtdf Ewnmg Aig	Essen	Germany
Uhdphgpyjp Dmmwm Slqlp Dj Rcok Lr Shtbfvdq	Rome	Italy
Ieurssho Cktyiu Dfzqmeulsangnpkei	L'hospitalet De Llobregat	Spain
Ufbzzustwc Hksiwryg Cwxzdin	Cologne	Germany
Etaxpqg Upfeoluyztny Mnaagny Cvhipzt Raulmvvaz (vovyyvs Mrk	Rotterdam	The Netherlands
Sgm Ehogsdbrb Hkklutsm Tnexcbt	Tilburg	The Netherlands
Koumfcjf dgt Utgsljamllab Mwrhxqdn Amo	Munich	Germany
Lapbj Ultcfzfxlein Mrogqjy Cqsgeup (pzlmk	Leiden	The Netherlands
Hjagklqg Ufctueghmglud Hodjrmqk Tudtv y Pylnsg Ibgttzvi Cfirzs dccxqxxznwqduojpf (cltv	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	19.03.2024
Belgium	Recruiting	19.03.2024
Czechia	Recruiting	19.03.2024
Denmark	Recruiting	19.03.2024
France	Recruiting	19.03.2024
Germany	Recruiting	19.03.2024
Italy	Recruiting	19.03.2024
Norway	Recruiting	19.03.2024
Spain	Recruiting	19.03.2024
The Netherlands	Recruiting	19.03.2024

Trial locations

Lomustine is a medication used in this trial to treat glioblastoma, a type of brain cancer. It works by slowing or stopping the growth of cancer cells. In this study, lomustine is being tested to see how effective it is when used alone.

Reirradiation is a therapy that involves giving radiation treatment to the brain again after the initial treatment. In this trial, reirradiation is combined with lomustine to see if this combination is more effective in improving survival for patients with glioblastoma compared to using lomustine alone.

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 infiltrating surrounding brain tissue. Symptoms can vary depending on the tumor’s location but may include headaches, seizures, and changes in personality or cognitive function. As the disease progresses, these symptoms typically worsen, and new neurological deficits may appear. Glioblastoma is characterized by its tendency to recur even after initial treatment. The disease is often diagnosed in adults and is considered one of the most common and malignant primary brain tumors.

Trial ID:

2023-505267-36-00

Protocol code:

EORTC 2227-BTG

NCT ID:

NCT05904119

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Lomustine with or without Additional Brain Radiation for Patients with Recurrent Glioblastoma

What is this study about?

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