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

• ClinicalTrials.gov Identifier: NCT03663725
• Recruitment Status: Recruiting
• First Posted: September 10, 2018
• Last Update Posted: July 20, 2022
• Sponsor: Centre Oscar Lambret
• Collaborators: Association de Neuro-Oncologues d'Expression Francaise; Erasme University Hospital
• Information provided by (Responsible Party): Centre Oscar Lambret

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 486 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: August 1, 2024
• Estimated Study Completion Date: November 1, 2026

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

France

Centre Hospitalier d'Amiens; Recruiting

Amiens, France, 80054

Contact: BOONE Mathieu, MD, PhD boone.mathieu@chu-amiens.fr

Sub-Investigator: Alexandre COUTTE, MD

Sub-Investigator: Etienne FESSART, MD

Sub-Investigator: Christine DESENCLOS, MD

Principal Investigator: Mathieu BOONE, MD

Sub-Investigator: Soraya RAMDANE, MD

Sub-Investigator: Farid BELKHIR, MD

ICO Centre Paul Papin; Withdrawn

Angers, France, 49055

Centre François Baclesse; Recruiting

Caen, France, 14076

Contact: Iona HRAB, MD i.hrab@baclesse-unicancer.fr

Principal Investigator: Iona HRAB, MD

Sub-Investigator: Lien BEKAERT, MD

Sub-Investigator: Julien GEFFRELOT, MD

Sub-Investigator: Dinu STEFAN, MD

Sub-Investigator: Evelyne EMERY, MD

Sub-Investigator: David Hassanein BERRO, MD

Centre Jean Perrin; Recruiting

Clermont-Ferrand, France, 63011

Contact: Xavier DURANDO, MD Xavier.Durando@clermont.unicancer.fr

Principal Investigator: Xavier DURANDO, MD

Sub-Investigator: Maureen BERNADACH, MD

Sub-Investigator: Guillaume DUPIC, MD

Sub-Investigator: Toufic KHALIL, MD

Hôpitaux Civils de Colmar; Recruiting

Colmar, France, 68024

Contact: Guido AHLE, MD guido.ahle@ch-colmar.fr

Principal Investigator: Guido AHLE, MD

Sub-Investigator: Claude GAULTIER, MD

Sub-Investigator: David ATLANI, MD

Sub-Investigator: Jimmy VOIRIN, MD

Centre Georges François Leclerc; Recruiting

Dijon, France, 21079

Contact: François GHIRINGELLI, MD, PhD fghiringhelli@cgfl.fr

Principal Investigator: François GHIRINGELLI, MD, PhD

Sub-Investigator: Julie VINCENT, MD

Sub-Investigator: Jean-François GUION, MD

Sub-Investigator: Gilles TRUC, MD

Sub-Investigator: Walid FARAH, MD

CHU Grenoble Alpes; Recruiting

Grenoble, France, 38043

Contact: Julien PAVILLET, MD jpavillet@chu-grenoble.fr

Principal Investigator: Julien PAVILLET, MD

Sub-Investigator: Coralie FRENOUX, MD

Sub-Investigator: Emmanuel DE SCHLICHTING, MD

CHU de Limoges; Recruiting

Limoges, France, 87042

Contact: Elise DELUCHE, MD françois.caire@chu-limoges.fr

Sub-Investigator: François CAIRE, MD

Sub-Investigator: Pierre CLAVERE, MD

Principal Investigator: Elise DELUCHE, MD

Sub-Investigator: Sandrine LAVAU-DENES, MD

Centre Léon Bérard; Recruiting

Lyon, France, 69673

Contact: Alice BONNEVILLE-LEVARD, MD Alice.BONNEVILLE-LEVARD@lyon.unicancer.fr

Principal Investigator: Alice BONNEVILLE-LEVARD, MD

Sub-Investigator: Didier FRAPPAZ, MD, PhD

Sub-Investigator: Marie Pierre SUNYACH, MD

Sub-Investigator: Coralie MONCHARMONT, MD

Sub-Investigator: Ronan TANGUY, MD

Sub-Investigator: Anne DURAND, MD

CHU La Timone; Recruiting

Marseille, France, 13385

Contact: Olivier CHINOT, MD olivier.chinot@ap-hm.fr

Principal Investigator: Maryline BARRIE, MD

Sub-Investigator: Chantal CAMPELLO, MD

Sub-Investigator: Gregorio PETRIRENA, MD

Sub-Investigator: Emeline TABOURET, MD

Sub-Investigator: Xavier MURACCIOLE, MD

Sub-Investigator: Henry DUFOUR, MD

Sub-Investigator: Thomas GRAILLON, MD

Sub-Investigator: Pierre Hugues ROCHE, MD

ICM Val d'Aurelle; Recruiting

Montpellier, France, 34298

Contact: Michel FABBRO, MD, PhD michel.fabbro@icm.unicancer.fr

Principal Investigator: Michel FABBRO, MD, PhD

Sub-Investigator: Marie CHASSIROUX, MD

Sub-Investigator: Christine KERR, MD

Sub-Investigator: Amélie DARLIX, MD

Sub-Investigator: Luc BAUCHET, MD

CHRU Nancy; Recruiting

Nancy, France, 54000

Contact: Luc TAILLANDIER, MD l.taillandier@chru-nancy.fr

Principal Investigator: Luc TAILLANDIER, MD

Sub-Investigator: Patrick BEAUCHESNE, MD

Sub-Investigator: Fabien RECH, MD

Sub-Investigator: Guillaume VOGIN, MD

ICO Centre René Gauducheau; Withdrawn

Nantes, France, 44805

CHU de Nice - Hôpital de Cimiez; Recruiting

Nice, France, 06000

Contact: Véronique BOURG, MD bourg.v@chu-nice.fr

Principal Investigator: Véronique BOURG, MD

Sub-Investigator: Christine LEBRUN-FRENAY, MD

Sub-Investigator: Fabien ALMAIRAC, MD

APHP La Pitié Salpêtrière; Recruiting

Paris, France, 75013

Contact: Khe HOANG XUAN, MD khe.hoang-xuan@aphp.fr

Sub-Investigator: Khe HOANG XUAN, MD

Sub-Investigator: Ahmed IDBAIH, MD

Sub-Investigator: Florence LAIGLE-DONADEY, MD

Principal Investigator: Agusti ALENTORN, MD

Sub-Investigator: Caroline DEHAIS, MD

Sub-Investigator: Caroline HOUILLIER, MD

Sub-Investigator: Dimitri PSIMARAS, MD

Sub-Investigator: Loïc FEUVRET, MD

Sub-Investigator: Alexandre CARPENTIER, MD

CH René Dubos; Recruiting

Pontoise, France, 95300

Contact: Claudia RIZZO, MD claudia.rizzo@ght-novo.fr

Principal Investigator: Claudia RIZZO, MD

Sub-Investigator: Denis NGUYEN, MD

Sub-Investigator: Emmanuel MANDONNET, MD

Institut Cancérologie Loire; Recruiting

Saint-Priest-en-Jarez, France, 42270

Contact: Carole RAMIREZ, MD carole.ramirez@icloire.fr

Principal Investigator: Carole RAMIREZ, MD

Sub-Investigator: Romain RIVOIRARD, MD

Sub-Investigator: Jane Chloé TRONE, MD

Sub-Investigator: Nicolas MAGNE, MD

Sub-Investigator: François VASSAL, MD

Sub-Investigator: Marie Jeannette MOTUO-FOTSO, MD

Centre Paul Strauss; Recruiting

Strasbourg, France, 67065

Contact: Roland SCHOTT, MD gnoel@strasbourg.unicancer.fr

Sub-Investigator: Georges NOEL, MD, PhD

Principal Investigator: Roland SCHOTT, MD

Sub-Investigator: Hélène CEBULA, MD

CHRU Tours; Recruiting

Tours, France, 37044

Contact: Ilyess ZEMMOURA, MD Ilyess.zemmoura@univ-tours.fr

Principal Investigator: Ilyess ZEMMOURA, MD

Sub-Investigator: Christophe DESTRIEUX, MD

Sub-Investigator: Bérengère NARCISO, MD

Sub-Investigator: Sophie CHAPET, MD

Sponsors and Collaborators

Centre Oscar Lambret

Association de Neuro-Oncologues d'Expression Francaise

Erasme University Hospital

Investigators

• Principal Investigator: Florence LEFRANC, MD; ERASME
• Principal Investigator: Bruno CHAUFFERT, MD; CHU Amiens

More Information

• Responsible Party: Centre Oscar Lambret
• ClinicalTrials.gov Identifier: NCT03663725
• Other Study ID Numbers: StrateGlio-1802; 2018-000410-38 ( EudraCT Number )
• First Posted: September 10, 2018
• Last Update Posted: July 20, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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