Treatment Intensification With Temozolomide in Adults With a Glioblastoma (StrateGlio)

Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Drug: Intensified protocol; Drug: Stupp protocol

• Study Type: Interventional
• Enrollment (Estimated): 486
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Centre Hospitalier d'Amiens
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Colmar, France, 68024
    • Hôpitaux Civils de Colmar
  • Dijon, France, 21079
    • Centre Georges Francois Leclerc
  • Grenoble, France, 38043
    • Chu Grenoble Alpes
  • Limoges, France, 87042
    • CHU de Limoges
  • Lyon, France, 69673
    • Centre Léon Bérard
  • Marseille, France, 13385
    • CHU La Timone
  • Montpellier, France, 34298
    • Icm Val D'Aurelle
  • Nancy, France, 54000
    • Chru Nancy
  • Nice, France, 06000
    • CHU de Nice - Hôpital de Cimiez
  • Paris, France, 75013
    • APHP La Pitié Salpêtrière
  • Pontoise, France, 95300
    • CH René Dubos
  • Saint-Priest-en-Jarez, France, 42270
    • Institut Cancérologie Loire
  • Strasbourg, France, 67065
    • Centre Paul Strauss
  • Tours, France, 37044
    • CHRU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensified protocol; Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ	Drug: 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)
Active Comparator: Stupp protocol; Concomitant Temozolomide (TMZ) Adjuvant TMZ	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	time interval from randomization to death whatever the cause	up to 18 months after recruitment of the last patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification	up to 18 months after recruitment of the last patient
Progression-free survival	time interval from randomization to the first occurrence of progression according to RANO criteria as assessed by the treating physician, or death whatever the cause	up to 18 months after recruitment of the last patient

Collaborators and Investigators

• Sponsor: Centre Oscar Lambret
• Collaborators: Erasme University Hospital; Association de Neuro-Oncologues d'Expression Francaise
• Investigators: Principal Investigator: Florence LEFRANC, MD, Erasme; Principal Investigator: Bruno CHAUFFERT, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: temozolomide; Stupp protocol
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: StrateGlio-1802; 2018-000410-38 (EudraCT Number); 2022-500451-23-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No