Clinical trial NCT03663725: Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Official title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glioblastoma
Keywords: temozolomide
Stupp protocol
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Association de Neuro-Oncologues d'Expression Francaise
name: Erasme University Hospital
First posted: 2018-09-10
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.


Eligibility criteria: Inclusion Criteria:

* Patient ≥18 years old
* 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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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:

* Secondary or recurrent glioblastoma (GBM)
* 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 18 months after recruitment of the last patient
Secondary outcomes:
measure: Number of adverse events
timeFrame: up to 18 months after recruitment of the last patient
measure: Progression-free survival
timeFrame: up to 18 months after recruitment of the last patient
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier d'Amiens
city: Angers
country: France
facility: ICO Centre Paul Papin
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: CHU La Timone
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nancy
country: France
facility: CHRU Nancy
city: Nantes
country: France
facility: ICO Centre René Gauducheau
city: Nice
country: France
facility: CHU de Nice - Hôpital de Cimiez
city: Paris
country: France
facility: APHP La Pitié Salpêtrière
city: Pontoise
country: France
facility: CH René Dubos
city: Saint-Priest-en-Jarez
country: France
facility: Institut Cancérologie Loire
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tours
country: France
facility: CHRU Tours
Study officials:
affiliation: ERASME
name: Florence LEFRANC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Bruno CHAUFFERT, MD
role: PRINCIPAL_INVESTIGATOR
References: