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Lomustine with or without a second round of brain radiation for the reappearance of glioblastoma
EU CTIS ID: 2023-505267-36-00
What this study is testing
The primary objective is to show that overall survival (OS) with lomustine plus reirradiation is superior compared to lomustine monotherapy for first progression of glioblastoma
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Before patient’s enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrolment
- Candidates for treatment with lomustine as per physician’s assessment.
- Patients of childbearing / reproductive potential must agree to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of study treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
- Patients with first progression or recurrent glioblastoma after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy with recurrence occuring at least 6 months after the end of Prior radiotherapy Prior first line therapy may include: Any systemic antineoplastic treatment other than nitroureas , Tumour-treating fields, Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
- Measurable disease according to RANO criteria with a maximum tumour diameter of 5 cm (local investigator assessment) Note 1: in case of multiple lesions, maximum cumulative CTV diameter of 5 cm treatable by 1 isocentre. Note 2: in case of surgery for recurrence, this criterion applies at the time of recurrence.
You likely can't join if
- Any prior anticancer treatment for recurrent glioblastoma (except surgery)
- Any serious or uncontrolled medical condition (e.g., infections, chronic alcoholism, drug addiction) or abnormality, in the judgment of the investigator that prohibits obtaining informed consent, safe participation and study completion
- Known contraindication to imaging tracer or any product of contrast media and Magnetic Resonance Imaging (MRI) contraindications
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
- Concurrent or recent history (30 days prior to lomustine initiation) of varicella (infection or exposure) and herpes zoster
- Known hereditary galactose intolerance, Lapp-lactase deficiency, or glucose-galactose malabsorption.
See the full eligibility criteria
Who can join
- Before patient’s enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrolment
- Candidates for treatment with lomustine as per physician’s assessment.
- Patients of childbearing / reproductive potential must agree to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of study treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
- Patients with first progression or recurrent glioblastoma after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy with recurrence occuring at least 6 months after the end of Prior radiotherapy Prior first line therapy may include: Any systemic antineoplastic treatment other than nitroureas , Tumour-treating fields, Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
- Measurable disease according to RANO criteria with a maximum tumour diameter of 5 cm (local investigator assessment) Note 1: in case of multiple lesions, maximum cumulative CTV diameter of 5 cm treatable by 1 isocentre. Note 2: in case of surgery for recurrence, this criterion applies at the time of recurrence.
- In case of surgery for recurrence: fully recovered from surgery, confirmation of recurrence by histology, and patient fit for treatment as per local investigator assessment. Note: residual and measurable disease after surgery is not required, provided that measurable disease was present before surgery.
- Histologically proven diagnosis of glioblastoma, IDH wildtype per WHO 2021 classification and local assessment of tissue from diagnosis or recurrence
- Stable or decreasing dose of steroids for 7 days prior to enrolment
- Age ≥ 18 years
- WHO Performance status of 0-2
What rules you out
- Any prior anticancer treatment for recurrent glioblastoma (except surgery)
- Any serious or uncontrolled medical condition (e.g., infections, chronic alcoholism, drug addiction) or abnormality, in the judgment of the investigator that prohibits obtaining informed consent, safe participation and study completion
- Known contraindication to imaging tracer or any product of contrast media and Magnetic Resonance Imaging (MRI) contraindications
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
- Concurrent or recent history (30 days prior to lomustine initiation) of varicella (infection or exposure) and herpes zoster
- Known hereditary galactose intolerance, Lapp-lactase deficiency, or glucose-galactose malabsorption.
- Patients with known pulmonary infiltration, interstitial pneumonia or pulmonary fibrosis and with a baseline below 70% of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DLCO)
- Significant reduction in thrombocyte and/or leukocyte counts (leukocytes < 4 x 10^9 /L and the platelets < 100 x 10^9 /L) as well as severe renal impairment according to investigator's opinion
- History or present acute leukaemia or any myeloid disease
- Known hypersensitivity to the active components or excipients of lomustine
- Known coeliac disease or wheat allergy
- Live attenuated vaccine in the 3 months prior to lomustine initiation
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.