GlioblastomaPhase 3StrateGlioNCT03663725
Treatment Intensification With Temozolomide in Adults With a Glioblastoma
A Phase 3 study testing Intensified protocol and Stupp protocol in people with Glioblastoma, run by Centre Oscar Lambret at 17 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Intensified protocol and Stupp protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 17 sitesFrance
- Study dates
- 13 Mar 2019to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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)
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Centre Hospitalier d'Amiens
Amiens, 80054
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Hôpitaux Civils de Colmar
Colmar, 68024
Centre Georges François Leclerc
Dijon, 21079
CHU Grenoble Alpes
Grenoble, 38043
CHU de Limoges
Limoges, 87042
Centre Léon Bérard
Lyon, 69673
CHU La Timone
Marseille, 13385
ICM Val d'Aurelle
Montpellier, 34298
CHRU Nancy
Nancy, 54000
CHU de Nice - Hôpital de Cimiez
Nice, 06000
APHP La Pitié Salpêtrière
Paris, 75013
CH René Dubos
Pontoise, 95300
Institut Cancérologie Loire
Saint-Priest-en-Jarez, 42270
Centre Paul Strauss
Strasbourg, 67065
CHRU Tours
Tours, 37044
About this study
Official title: Phase III Randomised Trial Evaluating 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.
- Conditions
- Glioblastoma
- Being tested
- Intensified protocol, Stupp protocol
- Keywords
- temozolomide, Stupp protocol
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified protocolDrug
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 protocolDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Intensified protocol | Experimental | Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ Receives: Drug: Intensified protocol |
| Stupp protocol | Active comparator | Concomitant Temozolomide (TMZ) Adjuvant TMZ Receives: Drug: Stupp protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
time interval from randomization to death whatever the cause
Measured: up to 18 months after recruitment of the last patient
Secondary outcomes (2)
Number of adverse events
from randomization until disease progression - reported and graded using the NCI-CTCAE v5.0 classification
Measured: up to 18 months after recruitment of the last patient
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
Measured: up to 18 months after recruitment of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start13 Mar 2019
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Association de Neuro-Oncologues d'Expression Francaise, Erasme University Hospital
- Responsible party
- Sponsor
- Investigators
- Florence LEFRANC, MD, Principal investigator, ERASMEBruno CHAUFFERT, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663725
- Sponsor's protocol ID
- StrateGlio-1802
- Other IDs
- 2022-500451-23-00, 2018-000410-38, 2018
- Acronym
- StrateGlio
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2018
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
- ClinicalTrials.gov ID
- NCT03663725
- Acronym / sponsor ID
- StrateGlio / StrateGlio-1802
- Conditions
- Glioblastoma
- Keywords
- temozolomide, Stupp protocol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Association de Neuro-Oncologues d'Expression Francaise, Erasme University Hospital
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified protocol | Experimental | Drug: Intensified protocolEarly Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ |
| Stupp protocol | Active comparator | Drug: Stupp protocolConcomitant Temozolomide (TMZ) Adjuvant TMZ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified protocolEarly 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) | Drug | Intensified protocol |
| Stupp protocolRT (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 | Drug | Stupp protocol |
Primary outcome
Overall Survival (OS)
Time frame: up to 18 months after recruitment of the last patient
time interval from randomization to death whatever the cause
2 secondary outcomes
Number of adverse events
Time frame: up to 18 months after recruitment of the last patient
Progression-free survival
Time frame: up to 18 months after recruitment of the last patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence LEFRANC, MD principal investigator
ERASME
Bruno CHAUFFERT, MD principal investigator
CHU Amiens
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensified protocol and Stupp protocol in people with Glioblastoma, run by Centre Oscar Lambret at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: up to 18 months after recruitment of the last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.