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

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ClinicalTrials.gov Identifier: NCT03663725
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Association de Neuro-Oncologues d’Expression Francaise
Erasme University Hospital
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Intensified protocol Drug: Stupp protocol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663725


Contacts
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Contact: Marie VANSEYMORTIER 33320295918 promotion@o-lambret.fr

Locations
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France
Centre Hospitalier d'Amiens Recruiting
Amiens, France
Contact: CHAUFFERT Bruno, MD PhD       Chauffert.Bruno@chu-amiens.fr   
Principal Investigator: Bruno CHAUFFERT, MD PhD         
Sponsors and Collaborators
Centre Oscar Lambret
Association de Neuro-Oncologues d’Expression Francaise
Erasme University Hospital
Investigators
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Principal Investigator: Florence LEFRANC, MD ERASME
Principal Investigator: Bruno CHAUFFERT, MD CHU Amiens

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03663725     History of Changes
Other Study ID Numbers: StrateGlio-1802
2018-000410-38 ( EudraCT Number )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Oscar Lambret:
temozolomide
Stupp protocol
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents