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Active, Not Recruiting

NCT Number: NCT03663725

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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

Treatment and study plan

Intensified protocol

Drug

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

Drug

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

Primary outcomes

  1. Overall Survival (OS)

    Time frame: up to 18 months after recruitment of the last patient

    time interval from randomization to death whatever the cause

Secondary outcomes

  1. Number of adverse events

    Time frame: up to 18 months after recruitment of the last patient

    from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification

  2. Progression-free survival

    Time frame: up to 18 months after recruitment of the last patient

    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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Association de Neuro-Oncologues d'Expression Francaise
  • Erasme University Hospital

Registry information

Official study title

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

Acronym: StrateGlio

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2018
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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