Clinical trial • Phase III • Oncology
Lomustine for Glioblastoma
Phase III trial of Lomustine for Glioblastoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Glioblastoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-10-2023
- First CTIS Authorization Date
- 20-02-2024
Trial design
Randomised, lomustine monotherapy versus lomustine plus reirradiation. lomustine is administered orally (dose units mg/m2; product metadata lists max total dose amount 200 mg and dose uom mg/m2). reirradiation is radiotherapy added to lomustine in the combination arm. (no detailed dose-schedule for lomustine or radiotherapy schedule provided in the ctis data.)-controlled Phase III trial in Austria, Czechia, Netherlands and others.
- Randomised
- Yes
- Comparator
- Lomustine monotherapy versus lomustine plus reirradiation. Lomustine is administered orally (dose units mg/m2; product metadata lists max total dose amount 200 mg and dose UoM mg/m2). Reirradiation is radiotherapy added to lomustine in the combination arm. (No detailed dose-schedule for lomustine or radiotherapy schedule provided in the CTIS data.)
- Target Sample Size
- 383
Eligibility
Recruits 383 Written informed consent must be given according to ICH/GCP and national/local regulations. Vulnerable population not selected for the study (isVulnerablePopulationSelected: false). Consent materials / ICFs are provided in multiple country languages and, where required, witnesses/interpreters have been used (documented in unexpected events)..
- Pregnancy Exclusion
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrolment
- Vulnerable Population
- Written informed consent must be given according to ICH/GCP and national/local regulations. Vulnerable population not selected for the study (isVulnerablePopulationSelected: false). Consent materials / ICFs are provided in multiple country languages and, where required, witnesses/interpreters have been used (documented in unexpected events).
Inclusion criteria
- {"criterion_text":"- Before patient’s enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.\n- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrolment\n- Candidates for treatment with lomustine as per physician’s assessment.\n- 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.\n- 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\n- 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.\n- 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.\n- Histologically proven diagnosis of glioblastoma, IDH wildtype per WHO 2021 classification and local assessment of tissue from diagnosis or recurrence\n- Stable or decreasing dose of steroids for 7 days prior to enrolment\n- Age ≥ 18 years\n- WHO Performance status of 0-2"}
Exclusion criteria
- {"criterion_text":"- Any prior anticancer treatment for recurrent glioblastoma (except surgery)\n- 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\n- Known contraindication to imaging tracer or any product of contrast media and Magnetic Resonance Imaging (MRI) contraindications\n- 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\n- Concurrent or recent history (30 days prior to lomustine initiation) of varicella (infection or exposure) and herpes zoster\n- Known hereditary galactose intolerance, Lapp-lactase deficiency, or glucose-galactose malabsorption.\n- 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)\n- 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\n- History or present acute leukaemia or any myeloid disease\n- Known hypersensitivity to the active components or excipients of lomustine\n- Known coeliac disease or wheat allergy\n- Live attenuated vaccine in the 3 months prior to lomustine initiation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is OS defined as the number of days from date of enrolment to the date of death due to any cause.","definition_or_measurement_approach":"OS defined as the number of days from date of enrolment to the date of death due to any cause."}
Secondary endpoints
- {"endpoint_text":"- PFS. Events are progressions based on Response Assessment in Neuro Oncology (RANO) criteria as determined by the local investigator","definition_or_measurement_approach":"Progression-free survival; events = progressions based on RANO criteria as determined by the local investigator."}
- {"endpoint_text":"- Objective and complete response per RANO criteria as assessed by the local investigator","definition_or_measurement_approach":"Objective and complete tumour response assessed locally per RANO criteria."}
- {"endpoint_text":"- Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting","definition_or_measurement_approach":"Safety assessed using CTCAE v5.0 for toxicity and SAE reporting."}
- {"endpoint_text":"- QDFS. A deterioration event is defined as ≥10-point worsening from baseline in the GHQ without further improvement (i.e., no subsequent ≥10 point improvement) or death due to any cause","definition_or_measurement_approach":"QoL deterioration-free survival (QDFS); deterioration event = ≥10-point worsening from baseline in global health quality (GHQ) without subsequent ≥10-point improvement, or death."}
- {"endpoint_text":"- Neurocognitive functioning assessed by Mini Mental State Examination (MMSE).","definition_or_measurement_approach":"Neurocognitive function measured by MMSE."}
- {"endpoint_text":"- Health utility, calculated from the collected patient-reported HRQoL data from the QLQ-C30 and patient demographics","definition_or_measurement_approach":"Health utility values derived from QLQ-C30 patient-reported HRQoL data and patient demographics for health economic analyses."}
- {"endpoint_text":"- Change scores. Changes in HRQoL from baseline in the GHQ/QoL, fatigue, nausea/vomiting, physical, role and social functioning scale scores assessed over time will be evaluated descriptively. Descriptive summaries such as median, range (minimum, maximum), IQR, mean and standard deviation will be provided for all the other scales from the QLQ-C30, QLQ-BN20 and the item list (IL46).","definition_or_measurement_approach":"Descriptive evaluation of changes from baseline in HRQoL scale scores (GHQ/QoL, fatigue, nausea/vomiting, physical, role, social functioning) with descriptive statistics (median, range, IQR, mean, SD) for QLQ-C30, QLQ-BN20, IL46 scales."}
Recruitment
- Planned Sample Size
- 383
- Recruitment Window Months
- 47
- Consent Approach
- Written informed consent must be given according to ICH/GCP and national/local regulations. Consent is provided by adult participants (study includes age ≥18). Subject information sheets and ICFs are available in multiple languages (documents in DE, IT, ES, DA, NL, FR, NO, CS, EN and country-specific ICFs are listed). Where needed, witnesses/interpreters have been used (documented unexpected event: enrolment of a non-French-speaking patient with witness/interpreter present).
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 371
Austria
- Earliest CTIS Part Ii Submission Date
- 29-01-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 32
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Neurology
- Principal Investigator Name
- Meinhard Nevinny-Stickel
- Principal Investigator Email
- meinhard.nevinny@i-med.ac.at
- Contact Person Name
- Meinhard Nevinny-Stickel
- Contact Person Email
- meinhard.nevinny@i-med.ac.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Neurology
- Principal Investigator Name
- Josef Pichler
- Principal Investigator Email
- josef.pichler@kepleruniklinikum.at
- Contact Person Name
- Josef Pichler
- Contact Person Email
- josef.pichler@kepleruniklinikum.at
- Site Name
- Medical University of Vienna
- Department Name
- Oncology
- Principal Investigator Name
- Anna Berghoff
- Principal Investigator Email
- anna.berghoff@meduniwien.ac.at
- Contact Person Name
- Anna Berghoff
- Contact Person Email
- anna.berghoff@meduniwien.ac.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-01-2024
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Oncology
- Principal Investigator Name
- Tomas Kazda
- Principal Investigator Email
- tomas.kazda@mou.cz
- Contact Person Name
- Tomas Kazda
- Contact Person Email
- tomas.kazda@mou.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-02-2024
- Latest Decision Or Authorization Date
- 21-02-2024
- Processing Time Days
- 6
- Number Of Sites
- 3
- Number Of Participants
- 37
Sites
- Site Name
- St. Elisabeth Hospital Tilburg
- Department Name
- Oncology
- Principal Investigator Name
- Laurens Beerepoot
- Principal Investigator Email
- L.Beerepoot@etz.nl
- Contact Person Name
- Laurens Beerepoot
- Contact Person Email
- L.Beerepoot@etz.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Oncology
- Principal Investigator Name
- Marjolein Geurts
- Principal Investigator Email
- m.geurts@erasmusmc.nl
- Contact Person Name
- Marjolein Geurts
- Contact Person Email
- m.geurts@erasmusmc.nl
- Site Name
- Leiden University Medical Center
- Department Name
- Oncology
- Principal Investigator Name
- Josefine Schopman
- Principal Investigator Email
- j.e.schopman@lumc.nl
- Contact Person Name
- Josefine Schopman
- Contact Person Email
- j.e.schopman@lumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 26-01-2024
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 25
- Number Of Sites
- 6
- Number Of Participants
- 62
Sites
- Site Name
- Istituto Oncologico Veneto
- Department Name
- Oncology
- Principal Investigator Name
- Giuseppe Lombardi
- Principal Investigator Email
- giuseppe.lombardi@iov.veneto.it
- Contact Person Name
- Giuseppe Lombardi
- Contact Person Email
- giuseppe.lombardi@iov.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Radiation-Oncology Unit
- Principal Investigator Name
- Lorenzo Livi
- Principal Investigator Email
- lorenzo.livi@unifi.it
- Contact Person Name
- Lorenzo Livi
- Contact Person Email
- lorenzo.livi@unifi.it
- Site Name
- Universita' Degli Studi Di Roma La Sapienza
- Department Name
- Oncology
- Principal Investigator Name
- Giuseppe Minniti
- Principal Investigator Email
- giuseppe.minniti@uniroma.it
- Contact Person Name
- Giuseppe Minniti
- Contact Person Email
- giuseppe.minniti@uniroma.it
- Site Name
- Instituto Di Ricovero E Cura A Carattere Scientifico
- Department Name
- Oncology
- Principal Investigator Name
- Enrico Franceschi
- Principal Investigator Email
- e.franceschi@ausl.bo.it
- Contact Person Name
- Enrico Franceschi
- Contact Person Email
- e.franceschi@ausl.bo.it
- Site Name
- Ospedale Mater Salutis Di Legnago
- Department Name
- Radiation oncology
- Principal Investigator Name
- Francesco Fiorica
- Principal Investigator Email
- francesco.fiorica@aulss9.veneto.it
- Contact Person Name
- Francesco Fiorica
- Contact Person Email
- francesco.fiorica@aulss9.veneto.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Radiation oncology
- Principal Investigator Name
- Pierina Navarria
- Principal Investigator Email
- piera.navarria@cancercenter.humanitas.it
- Contact Person Name
- Pierina Navarria
- Contact Person Email
- piera.navarria@cancercenter.humanitas.it
Spain
- Earliest CTIS Part Ii Submission Date
- 15-01-2024
- Latest Decision Or Authorization Date
- 21-02-2024
- Processing Time Days
- 37
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Virginia Rodriguez
- Principal Investigator Email
- virginia.rod.gon@gmail.com
- Contact Person Name
- Virginia Rodriguez
- Contact Person Email
- virginia.rod.gon@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Anna Lucas Calduch
- Principal Investigator Email
- alucas@iconcologia.net
- Contact Person Name
- Anna Lucas Calduch
- Contact Person Email
- alucas@iconcologia.net
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Principal Investigator Name
- Silvia Comas Anton
- Principal Investigator Email
- scomas@iconcologia.net
- Contact Person Name
- Silvia Comas Anton
- Contact Person Email
- scomas@iconcologia.net
Belgium
- Earliest CTIS Part Ii Submission Date
- 24-01-2024
- Latest Decision Or Authorization Date
- 22-02-2024
- Processing Time Days
- 29
- Number Of Sites
- 6
- Number Of Participants
- 33
Sites
- Site Name
- Azorg
- Department Name
- Oncology
- Principal Investigator Name
- Samuel Bral
- Principal Investigator Email
- Samuel.Bral@azorg.be
- Contact Person Name
- Samuel Bral
- Contact Person Email
- Samuel.Bral@azorg.be
- Site Name
- UZ Leuven
- Department Name
- Oncology
- Principal Investigator Name
- Maarten Lambrecht
- Principal Investigator Email
- maarten.lambrecht@uzleuven.be
- Contact Person Name
- Maarten Lambrecht
- Contact Person Email
- maarten.lambrecht@uzleuven.be
- Site Name
- Ziekenhuis Aan De Stroom
- Department Name
- Oncology Centre
- Principal Investigator Name
- Katrien Erven
- Principal Investigator Email
- katrien.erven@zas.be
- Contact Person Name
- Katrien Erven
- Contact Person Email
- katrien.erven@zas.be
- Site Name
- Grand Hopital De Charleroi
- Department Name
- Oncology
- Principal Investigator Name
- Vincent Verschaeve
- Principal Investigator Email
- vincent.verschaeve@ghdc.be
- Contact Person Name
- Vincent Verschaeve
- Contact Person Email
- vincent.verschaeve@ghdc.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Principal Investigator Name
- Dario Di Perri
- Principal Investigator Email
- dario.diperri@saintluc.uclouvain.be
- Contact Person Name
- Dario Di Perri
- Contact Person Email
- dario.diperri@saintluc.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Radiotherapy
- Principal Investigator Name
- Tom Boterberg
- Principal Investigator Email
- tom.boterberg@ugent.be
- Contact Person Name
- Tom Boterberg
- Contact Person Email
- tom.boterberg@ugent.be
France
- Earliest CTIS Part Ii Submission Date
- 13-12-2023
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 75
- Number Of Sites
- 9
- Number Of Participants
- 97
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mathieu Boone
- Principal Investigator Email
- boone.mathieu@chu-amiens.fr
- Contact Person Name
- Mathieu Boone
- Contact Person Email
- boone.mathieu@chu-amiens.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Radiotherapy
- Principal Investigator Name
- Florine Tomaszewski
- Principal Investigator Email
- Florine.tomaszewski@ico.unicancer.fr
- Contact Person Name
- Florine Tomaszewski
- Contact Person Email
- Florine.tomaszewski@ico.unicancer.fr
- Site Name
- Institut De Cancerologie Strasbourg Europe
- Department Name
- Medical Oncology
- Principal Investigator Name
- Roland Schott
- Principal Investigator Email
- r.schott@icans.eu
- Contact Person Name
- Roland Schott
- Contact Person Email
- r.schott@icans.eu
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Neurology
- Principal Investigator Name
- Véronique Bourg
- Principal Investigator Email
- bourg.v@chu-nice.fr
- Contact Person Name
- Véronique Bourg
- Contact Person Email
- bourg.v@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Neurology
- Principal Investigator Name
- Apolline Monfilliette-Djelad
- Principal Investigator Email
- apolline.djelad@chru-lille.fr
- Contact Person Name
- Apolline Monfilliette-Djelad
- Contact Person Email
- apolline.djelad@chru-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Radiation oncology
- Principal Investigator Name
- Julian Jacob
- Principal Investigator Email
- Julian.jacob@aphp.fr
- Contact Person Name
- Julian Jacob
- Contact Person Email
- Julian.jacob@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Neuro-Oncology
- Principal Investigator Name
- François Ducray
- Principal Investigator Email
- francois.ducray@chu-lyon.fr
- Contact Person Name
- François Ducray
- Contact Person Email
- francois.ducray@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Neurology
- Principal Investigator Name
- Stefania Cuzzubbo
- Principal Investigator Email
- stefania.cuzzubbo@aphp.fr
- Contact Person Name
- Stefania Cuzzubbo
- Contact Person Email
- stefania.cuzzubbo@aphp.fr
- Site Name
- Centre Jean Perrin
- Department Name
- Oncology & Clinical Research
- Principal Investigator Name
- Xavier Durando
- Principal Investigator Email
- xavier.durando@clermont.unicancer.fr
- Contact Person Name
- Xavier Durando
- Contact Person Email
- xavier.durando@clermont.unicancer.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Region Midtjylland
- Department Name
- clinical oncology
- Principal Investigator Name
- Slavka Lucacova
- Principal Investigator Email
- slvkluka@rm.dk
- Contact Person Name
- Slavka Lucacova
- Contact Person Email
- slvkluka@rm.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 14-02-2024
- Latest Decision Or Authorization Date
- 21-02-2024
- Processing Time Days
- 7
- Number Of Sites
- 7
- Number Of Participants
- 56
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Neurology
- Principal Investigator Name
- Ghazaleh Tabatabai
- Principal Investigator Email
- ghazaleh.tabatabai@uni-tuebingen.de
- Contact Person Name
- Ghazaleh Tabatabai
- Contact Person Email
- ghazaleh.tabatabai@uni-tuebingen.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Neurology
- Principal Investigator Name
- Louisa Von Baumgarten
- Principal Investigator Email
- Louisa.vonBaumgarten@med.uni-muenchen.de
- Contact Person Name
- Louisa Von Baumgarten
- Contact Person Email
- Louisa.vonBaumgarten@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Neurology
- Principal Investigator Name
- Antje Wick
- Principal Investigator Email
- antje.wick@med.uni-heidelberg.de
- Contact Person Name
- Antje Wick
- Contact Person Email
- antje.wick@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Neurology
- Principal Investigator Name
- Sied Kebir
- Principal Investigator Email
- sied.kebir@uk-essen.de
- Contact Person Name
- Sied Kebir
- Contact Person Email
- sied.kebir@uk-essen.de
- Site Name
- Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
- Department Name
- Neurology
- Principal Investigator Name
- Corinna Seliger-Behme
- Principal Investigator Email
- corinna.seliger-Behme@kk-bochum.de
- Contact Person Name
- Corinna Seliger-Behme
- Contact Person Email
- corinna.seliger-Behme@kk-bochum.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Neurology
- Principal Investigator Name
- norbert galldiks
- Principal Investigator Email
- norbert.galldiks@uk-koeln.de
- Contact Person Name
- norbert galldiks
- Contact Person Email
- norbert.galldiks@uk-koeln.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Neurosurgery
- Principal Investigator Name
- Christian Senft
- Principal Investigator Email
- christian.senft@med.uni-jena.de
- Contact Person Name
- Christian Senft
- Contact Person Email
- christian.senft@med.uni-jena.de
Norway
- Earliest CTIS Part Ii Submission Date
- 24-01-2024
- Latest Decision Or Authorization Date
- 20-02-2024
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Oncology
- Principal Investigator Name
- Petter Brandal
- Principal Investigator Email
- petter.brandal@ous-hf.no
- Contact Person Name
- Petter Brandal
- Contact Person Email
- petter.brandal@ous-hf.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Oncology
- Principal Investigator Name
- Tora S. Solheim
- Principal Investigator Email
- tora.s.solheim@ntnu.no
- Contact Person Name
- Tora S. Solheim
- Contact Person Email
- tora.s.solheim@ntnu.no
Sponsor
Primary sponsor
- Full Name
- European Organisation For Research And Treatment Of Cancer
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Belgium
Third parties
- {"country":"United Kingdom","full_name":"Klinikos Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- LOMUSTINE
- Active Substance
- Lomustine
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 200 mg
- Combination Treatment
- Yes
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