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

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

Lomustine – Lomustine is administered orally in capsule form. It is currently being studied in clinical trials for its effectiveness in treating glioblastoma, particularly in combination with reirradiation. The main therapeutic indication for lomustine is the treatment of brain tumors, including glioblastoma. At the molecular level, lomustine works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It is classified as an alkylating agent, which is a type of chemotherapy drug that damages the DNA of cancer cells to stop their proliferation.

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 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505267-36-00Protocol codeEORTC 2227-BTGEstimated enrolment411 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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