Treatment Intensification With Temozolomide in Adults With a Glioblastoma
NCT ID: NCT03663725
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
486 participants
INTERVENTIONAL
2019-03-13
2028-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensified protocol
Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ
Intensified protocol
Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)
Stupp protocol
Concomitant Temozolomide (TMZ) Adjuvant TMZ
Stupp protocol
RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ
Interventions
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Intensified protocol
Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)
Stupp protocol
RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ
Eligibility Criteria
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Inclusion Criteria
* Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study.
* Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days)
* Karnofsky performance status (KPS) ≥ 60%, or KPS \<60% only related to glioma-related motor paresis.
* Adequate biological functions
* Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms)
* Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug.
* Standard radiation therapy deemed feasible (60 Gy, 30 fractions)
* Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy
* Written informed consent
Exclusion Criteria
* Planned use of tumor-treating electric fields
* Planned use of Carmustine implants
* Prior malignancy in the last 5 years before inclusion or concomitant
* Severe myelosuppression
* Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC)
* Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion).
* Known current viral hepatitis, HIV infection or current active infectious disease
* Inability to swallow oral medications or any mal-absorption condition
* Pregnant or breastfeeding patients.
* Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
* Person under guardianship or curatorship
18 Years
ALL
No
Sponsors
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Association de Neuro-Oncologues d'Expression Francaise
OTHER
Erasme University Hospital
OTHER
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Florence LEFRANC, MD
Role: PRINCIPAL_INVESTIGATOR
ERASME
Bruno CHAUFFERT, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Amiens
Locations
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Centre Hospitalier d'Amiens
Amiens, , France
ICO Centre Paul Papin
Angers, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hôpitaux Civils de Colmar
Colmar, , France
Centre Georges François Leclerc
Dijon, , France
CHU Grenoble Alpes
Grenoble, , France
CHU de Limoges
Limoges, , France
Centre Léon Bérard
Lyon, , France
CHU La Timone
Marseille, , France
ICM Val d'Aurelle
Montpellier, , France
CHRU Nancy
Nancy, , France
ICO Centre René Gauducheau
Nantes, , France
CHU de Nice - Hôpital de Cimiez
Nice, , France
APHP La Pitié Salpêtrière
Paris, , France
CH René Dubos
Pontoise, , France
Institut Cancérologie Loire
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
CHRU Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-000410-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
StrateGlio-1802
Identifier Type: -
Identifier Source: org_study_id
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