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

Primary Purpose

Glioblastoma

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Intensified protocol
Stupp protocol
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring temozolomide, Stupp protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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

Sites / Locations

  • Centre Hospitalier d'AmiensRecruiting
  • ICO Centre Paul Papin
  • Centre François BaclesseRecruiting
  • Centre Jean PerrinRecruiting
  • Hôpitaux Civils de ColmarRecruiting
  • Centre Georges François LeclercRecruiting
  • CHU Grenoble AlpesRecruiting
  • CHU de LimogesRecruiting
  • Centre Léon BérardRecruiting
  • CHU La TimoneRecruiting
  • ICM Val d'AurelleRecruiting
  • CHRU NancyRecruiting
  • ICO Centre René Gauducheau
  • CHU de Nice - Hôpital de CimiezRecruiting
  • APHP La Pitié SalpêtrièreRecruiting
  • CH René DubosRecruiting
  • Institut Cancérologie LoireRecruiting
  • Centre Paul StraussRecruiting
  • CHRU ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensified protocol

Stupp protocol

Arm Description

Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ

Concomitant Temozolomide (TMZ) Adjuvant TMZ

Outcomes

Primary Outcome Measures

Overall Survival (OS)
time interval from randomization to death whatever the cause

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2018
Last Updated
July 19, 2022
Sponsor
Centre Oscar Lambret
Collaborators
Association de Neuro-Oncologues d'Expression Francaise, Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03663725
Brief Title
Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Acronym
StrateGlio
Official Title
Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Association de Neuro-Oncologues d'Expression Francaise, Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
temozolomide, Stupp protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
486 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensified protocol
Arm Type
Experimental
Arm Description
Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ
Arm Title
Stupp protocol
Arm Type
Active Comparator
Arm Description
Concomitant Temozolomide (TMZ) Adjuvant TMZ
Intervention Type
Drug
Intervention Name(s)
Intensified protocol
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Stupp protocol
Intervention Description
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 Measure Information:
Title
Overall Survival (OS)
Description
time interval from randomization to death whatever the cause
Time Frame
up to 18 months after recruitment of the last patient
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification
Time Frame
up to 18 months after recruitment of the last patient
Title
Progression-free survival
Description
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
Time Frame
up to 18 months after recruitment of the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie VANSEYMORTIER
Phone
33320295918
Email
promotion@o-lambret.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence LEFRANC, MD
Organizational Affiliation
ERASME
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno CHAUFFERT, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOONE Mathieu, MD, PhD
Email
boone.mathieu@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Alexandre COUTTE, MD
First Name & Middle Initial & Last Name & Degree
Etienne FESSART, MD
First Name & Middle Initial & Last Name & Degree
Christine DESENCLOS, MD
First Name & Middle Initial & Last Name & Degree
Mathieu BOONE, MD
First Name & Middle Initial & Last Name & Degree
Soraya RAMDANE, MD
First Name & Middle Initial & Last Name & Degree
Farid BELKHIR, MD
Facility Name
ICO Centre Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iona HRAB, MD
Email
i.hrab@baclesse-unicancer.fr
First Name & Middle Initial & Last Name & Degree
Iona HRAB, MD
First Name & Middle Initial & Last Name & Degree
Lien BEKAERT, MD
First Name & Middle Initial & Last Name & Degree
Julien GEFFRELOT, MD
First Name & Middle Initial & Last Name & Degree
Dinu STEFAN, MD
First Name & Middle Initial & Last Name & Degree
Evelyne EMERY, MD
First Name & Middle Initial & Last Name & Degree
David Hassanein BERRO, MD
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD
Email
Xavier.Durando@clermont.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO, MD
First Name & Middle Initial & Last Name & Degree
Maureen BERNADACH, MD
First Name & Middle Initial & Last Name & Degree
Guillaume DUPIC, MD
First Name & Middle Initial & Last Name & Degree
Toufic KHALIL, MD
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guido AHLE, MD
Email
guido.ahle@ch-colmar.fr
First Name & Middle Initial & Last Name & Degree
Guido AHLE, MD
First Name & Middle Initial & Last Name & Degree
Claude GAULTIER, MD
First Name & Middle Initial & Last Name & Degree
David ATLANI, MD
First Name & Middle Initial & Last Name & Degree
Jimmy VOIRIN, MD
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François GHIRINGELLI, MD, PhD
Email
fghiringhelli@cgfl.fr
First Name & Middle Initial & Last Name & Degree
François GHIRINGELLI, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julie VINCENT, MD
First Name & Middle Initial & Last Name & Degree
Jean-François GUION, MD
First Name & Middle Initial & Last Name & Degree
Gilles TRUC, MD
First Name & Middle Initial & Last Name & Degree
Walid FARAH, MD
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien PAVILLET, MD
Email
jpavillet@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Julien PAVILLET, MD
First Name & Middle Initial & Last Name & Degree
Coralie FRENOUX, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel DE SCHLICHTING, MD
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise DELUCHE, MD
Email
françois.caire@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
François CAIRE, MD
First Name & Middle Initial & Last Name & Degree
Pierre CLAVERE, MD
First Name & Middle Initial & Last Name & Degree
Elise DELUCHE, MD
First Name & Middle Initial & Last Name & Degree
Sandrine LAVAU-DENES, MD
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69673
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice BONNEVILLE-LEVARD, MD
Email
Alice.BONNEVILLE-LEVARD@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Alice BONNEVILLE-LEVARD, MD
First Name & Middle Initial & Last Name & Degree
Didier FRAPPAZ, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marie Pierre SUNYACH, MD
First Name & Middle Initial & Last Name & Degree
Coralie MONCHARMONT, MD
First Name & Middle Initial & Last Name & Degree
Ronan TANGUY, MD
First Name & Middle Initial & Last Name & Degree
Anne DURAND, MD
Facility Name
CHU La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier CHINOT, MD
Email
olivier.chinot@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Maryline BARRIE, MD
First Name & Middle Initial & Last Name & Degree
Chantal CAMPELLO, MD
First Name & Middle Initial & Last Name & Degree
Gregorio PETRIRENA, MD
First Name & Middle Initial & Last Name & Degree
Emeline TABOURET, MD
First Name & Middle Initial & Last Name & Degree
Xavier MURACCIOLE, MD
First Name & Middle Initial & Last Name & Degree
Henry DUFOUR, MD
First Name & Middle Initial & Last Name & Degree
Thomas GRAILLON, MD
First Name & Middle Initial & Last Name & Degree
Pierre Hugues ROCHE, MD
Facility Name
ICM Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel FABBRO, MD, PhD
Email
michel.fabbro@icm.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Michel FABBRO, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marie CHASSIROUX, MD
First Name & Middle Initial & Last Name & Degree
Christine KERR, MD
First Name & Middle Initial & Last Name & Degree
Amélie DARLIX, MD
First Name & Middle Initial & Last Name & Degree
Luc BAUCHET, MD
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc TAILLANDIER, MD
Email
l.taillandier@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Luc TAILLANDIER, MD
First Name & Middle Initial & Last Name & Degree
Patrick BEAUCHESNE, MD
First Name & Middle Initial & Last Name & Degree
Fabien RECH, MD
First Name & Middle Initial & Last Name & Degree
Guillaume VOGIN, MD
Facility Name
ICO Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU de Nice - Hôpital de Cimiez
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique BOURG, MD
Email
bourg.v@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Véronique BOURG, MD
First Name & Middle Initial & Last Name & Degree
Christine LEBRUN-FRENAY, MD
First Name & Middle Initial & Last Name & Degree
Fabien ALMAIRAC, MD
Facility Name
APHP La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khe HOANG XUAN, MD
Email
khe.hoang-xuan@aphp.fr
First Name & Middle Initial & Last Name & Degree
Khe HOANG XUAN, MD
First Name & Middle Initial & Last Name & Degree
Ahmed IDBAIH, MD
First Name & Middle Initial & Last Name & Degree
Florence LAIGLE-DONADEY, MD
First Name & Middle Initial & Last Name & Degree
Agusti ALENTORN, MD
First Name & Middle Initial & Last Name & Degree
Caroline DEHAIS, MD
First Name & Middle Initial & Last Name & Degree
Caroline HOUILLIER, MD
First Name & Middle Initial & Last Name & Degree
Dimitri PSIMARAS, MD
First Name & Middle Initial & Last Name & Degree
Loïc FEUVRET, MD
First Name & Middle Initial & Last Name & Degree
Alexandre CARPENTIER, MD
Facility Name
CH René Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia RIZZO, MD
Email
claudia.rizzo@ght-novo.fr
First Name & Middle Initial & Last Name & Degree
Claudia RIZZO, MD
First Name & Middle Initial & Last Name & Degree
Denis NGUYEN, MD
First Name & Middle Initial & Last Name & Degree
Emmanuel MANDONNET, MD
Facility Name
Institut Cancérologie Loire
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carole RAMIREZ, MD
Email
carole.ramirez@icloire.fr
First Name & Middle Initial & Last Name & Degree
Carole RAMIREZ, MD
First Name & Middle Initial & Last Name & Degree
Romain RIVOIRARD, MD
First Name & Middle Initial & Last Name & Degree
Jane Chloé TRONE, MD
First Name & Middle Initial & Last Name & Degree
Nicolas MAGNE, MD
First Name & Middle Initial & Last Name & Degree
François VASSAL, MD
First Name & Middle Initial & Last Name & Degree
Marie Jeannette MOTUO-FOTSO, MD
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland SCHOTT, MD
Email
gnoel@strasbourg.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Georges NOEL, MD, PhD
First Name & Middle Initial & Last Name & Degree
Roland SCHOTT, MD
First Name & Middle Initial & Last Name & Degree
Hélène CEBULA, MD
Facility Name
CHRU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilyess ZEMMOURA, MD
Email
Ilyess.zemmoura@univ-tours.fr
First Name & Middle Initial & Last Name & Degree
Ilyess ZEMMOURA, MD
First Name & Middle Initial & Last Name & Degree
Christophe DESTRIEUX, MD
First Name & Middle Initial & Last Name & Degree
Bérengère NARCISO, MD
First Name & Middle Initial & Last Name & Degree
Sophie CHAPET, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment Intensification With Temozolomide in Adults With a Glioblastoma

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