Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Glioblastoma Clinical Trial

— StrateGlio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03663725
• Other study ID #: StrateGlio-1802
• Secondary ID: 2018-000410-38
• Status: Recruiting
• Phase: Phase 3
• Start date: March 13, 2019
• Est. completion date: November 1, 2027

Study information

• Verified date: February 2024
• Source: Centre Oscar Lambret
• Contact: Marie VANSEYMORTIER
• Phone: 33320295918
• Email: promotion[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 486
• Est. completion date: November 1, 2027
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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)
• 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

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Association de Neuro-Oncologues d'Expression Francaise, Erasme University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	time interval from randomization to death whatever the cause	up to 18 months after recruitment of the last patient
Secondary	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
Secondary	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