Trial Title:
Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study
NCT ID:
NCT05904119
Condition:
First Progression of Glioblastoma
Conditions: Official terms:
Glioblastoma
Disease Progression
Lomustine
Conditions: Keywords:
First progression
Glioblastoma
Phase III
Lomustine
Reirradiation
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lomustine
Description:
Oral administration of Lomustine
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Radiation
Intervention name:
Reirradiation
Description:
Given at least 6 months after the end of prior radiotherapy
Arm group label:
Experimental group
Summary:
Despite comprehensive multimodal treatment of newly diagnosed glioblastoma, almost all
patients suffer from tumour relapse. Currently, no standard of care exists to treat these
tumour relapses. Treatment options include repeated surgery (if feasible), systemic
therapy (bevacizumab, lomustine, temozolomide re-challenge), reirradiation and best
supportive care. Currently, the superiority of combined chemoradiation versus
chemotherapy alone remains unproven. Given that lomustine is the standard
chemotherapeutic agent for the treatment of recurrent glioblastoma in Europe and the
unclear efficacy of reirradiation, we want to explore whether combining lomustine and
reirradiation may be a better treatment than lomustine alone. The results of the
prospective randomized trial proposed here should demonstrate a significant improvement
in overall survival when lomustine is combined with reirradiation in patients with
recurrent glioblastoma compared to lomustine alone without adversely affecting quality of
survival. The trial will be stopped based on overall survival in a preplanned futility
and efficacy interim analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Before patient's enrolment, written informed consent must be given according to
ICH/GCP, and national/local regulations.
- Patients with first progression or recurrent glioblastoma after standard
chemoradiotherapy (any treatment other than use of nitroureas) having occurred at
least 6 months after the end of prior radiotherapy
- Measurable disease according to RANO criteria with a maximum tumour diameter of 5 cm
(local investigator assessment)
- 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.
- Histologically proven diagnosis of glioblastoma, IDH wildtype per WHO 2021
classification and local assessment of tissue from diagnosis or recurrence
- Initial treatment of newly diagnosed glioblastoma by maximal safe resection and
postsurgical concurrent conventionally fractionated or abbreviated (minimum 15
fractions) chemoradiotherapy with or without maintenance chemotherapy with
temozolomide (patient must have received at least one dose)
- Stable or decreasing dose of steroids for 7 days prior to enrolment
- Age ≥ 18 years
- WHO Performance status of 0-2
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
within 7 days prior to the first dose of study treatment.
- 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.
- Female subjects who are breast feeding should discontinue nursing prior to the first
dose of study treatment and until 6 months after the last study treatment.
- Non-sterile males must use contraception during treatment and for 6 months after the
last dose.
- Non-sterile males must avoid sperm donation for the duration of the study and for at
least 6 months after the last dose of study treatment.
Exclusion Criteria:
- Any prior anticancer treatment for recurrent glioblastoma (except surgery)
- Significant reduction in thrombocyte and/or leukocyte counts 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
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Kepler University Hospital - Neuromed campus
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Wien - AKH unikliniken
Address:
City:
Vienna
Country:
Austria
Status:
Recruiting
Facility:
Name:
Masaryk Memorial Cancer Institute
Address:
City:
Brno
Country:
Czechia
Status:
Recruiting
Facility:
Name:
CHU d'Amiens - CHU Amiens Picardie - Site Sud
Address:
City:
Amiens
Zip:
80054
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Facility:
Name:
Institut du Cancer de Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Facility:
Name:
Assistance Publique Hopitaux Paris- APHP - APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (233)
Address:
City:
Paris
Zip:
75013
Country:
France
Status:
Recruiting
Facility:
Name:
Assistance Publique Hopitaux Paris- APHP - APHP Nord - Univ De Paris Cite - Hop. Saint Louis
Address:
City:
Paris
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de Cancerologie de l´Ouest (ICO) - Saint Herblain
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Univ. Knappschaft Krankenhaus Bochum
Address:
City:
Bochum
Zip:
44892
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Erlangen-Schwabachanlage
Address:
City:
Erlangen
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Leipzig-Klinik für Strahlentherapie und Radioonkologie
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Regensburg
Address:
City:
Regensburg
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Tuebingen- Crona Kliniken
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Facility:
Name:
ULSS 9 Scaligera Veneto - Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Address:
City:
Legnago
Zip:
37045
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS - Istituto Oncologico Veneto
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Medisch Spectrum Twente
Address:
City:
Enschede
Zip:
7512 KZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Leiden University Medical Centre
Address:
City:
Leiden
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Address:
City:
Badalona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (381)
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
Address:
City:
Hospitalet De Llobregat
Zip:
08908
Country:
Spain
Status:
Recruiting
Start date:
March 15, 2024
Completion date:
February 2028
Lead sponsor:
Agency:
European Organisation for Research and Treatment of Cancer - EORTC
Agency class:
Other
Collaborator:
Agency:
Swiss Group for Clinical Cancer Research
Agency class:
Other
Source:
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05904119
