GlioblastomaPhase 2GLIOPLAKNCT02617745
Impact of the Platelet Level in Patients Treated for Glioblastoma With Temozolomid
A Phase 2 study testing Platelet level determination in people with Glioblastoma, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Platelet level determination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2015to 5 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age Superior to 18 years
- Inform consent form signed
- Newly diagnosed (histologically) glioblastoma
- Stupp protocol treatment
- with social insurance
Who cannot join
- Not inform consent form signed
- participation to another clinical trial
- other cancer
- background of hematological pathology
- patient under guardianship, curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Platelet Level During Radiotherapy Associated With Temozolomide in Patients Treated for Glioblastoma
The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed.
Read the detailed description
Glioblastoma is the most common primitive cerebral tumor. Currently its optimal treatment is based on a multidisciplinary approach combining an initial surgical resection, if feasible, then Stupp protocol. Stupp protocol consists of two phases: first phase involves external radiotherapy with concomitant oral temozolomide at a dose of 75mg/m2 per day for about six weeks. After 4 weeks of therapy break, maintenance phase begins with temozolomide alone, for a period of 6 cycles (1 cycle = 5 days over 28). The dose of temozolomide is 150mg/m2 on the first cycle followed by 200 mg/m2. One major limiting toxicity of temozolomide is hematologic, especially thrombocytopenia. They occur in around 15 and 20% of patients in maintenance phase. Thrombocytopenia has an impact on the schedule of Stupp protocol such as dose reduction or even early discontinuation. Currently no predictive marker of thrombocytopenia in the maintenance phase was identified. Such marker could be of major interest to adapt biological and clinical follow-up by patient in maintenance phase. We conduct a retrospective analysis on a cohort of patients suffering from glioblastoma and treated with Stupp protocol. We found that a decrease in platelet count during the radio-chemotherapy phase could be highly predictive of protocol changes in maintenance phase of temozolomide due to thrombocytopenia. The main objective of GLIOPLAK is to prospectively confirm the predictive value of this test and to evaluate the prognostic impact of the occurrence of thrombocytopenia <100,000/mm3. Secondary objective of GLIOPLAK are to describe all limiting toxicities in maintenance phase, to constitute a prospective biological collection and to collect biological samples to perform pharmacological analysis (pharmacogenomics and pharmacokinetics parameters).
- Conditions
- Glioblastoma
- Being tested
- Platelet level determination
- Keywords
- Stupp protocol, glioblastoma, thrombocytopenia
- Medical subject headings
- Glioblastoma, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet level determinationOther
evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. For this the platelet level will be determined each wek during the radiotherapy phase and each cycle during the chemotherapy phase
| Study group | Role | What they receive |
|---|---|---|
| Stupp protocol | Experimental | Blood assessment of the platelet level every week during the radiotherapy phase and every cycle during the chemotherapy Receives: Other: Platelet level determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of time where platelet level was Under 100 000 per mm3
Determination of platelet level to predict the risk of thrombocytopenia
Measured: one year and 6 months
Secondary outcomes (2)
Overall survival
time between inclusion and death
Measured: 3 years
Therapeutic modifications
Proportion of patient with treatment modifications
Measured: one year and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start30 Nov 2015
- Primary completion28 Nov 2022
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic Di Fiore, MD, PhD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617745
- Sponsor's protocol ID
- CHB 15.02
- Acronym
- GLIOPLAK
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2015
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Fontanilles M, Heisbourg JD, Daban A, Di Fiore F, Pepin LF, Marguet F, Langlois O, Alexandru C, Tennevet I, Ducatez F, Pilon C, Plichet T, Mokbel D, Lesueur C, Bekri S, Tebani A. Metabolic remodeling in glioblastoma: a longitudinal multi-omics study. Acta Neuropathol Commun. 2024 Oct 12;12(1):162. doi: 10.1186/s40478-024-01861-5.
PubMed 39394177Daban A, Beaussire-Trouvay L, Leveque E, Alexandru C, Tennevet I, Langlois O, Veresezan O, Marguet F, Clatot F, Di Fiore F, Sarafan-Vasseur N, Fontanilles M. Prognostic value of circulating short-length DNA fragments in unresected glioblastoma patients. Transl Oncol. 2024 Apr;42:101897. doi: 10.1016/j.tranon.2024.101897. Epub 2024 Feb 9.
PubMed 38340682Fontanilles M, Marguet F, Beaussire L, Magne N, Pepin LF, Alexandru C, Tennevet I, Hanzen C, Langlois O, Jardin F, Laquerriere A, Sarafan-Vasseur N, Di Fiore F, Clatot F. Cell-free DNA and circulating TERT promoter mutation for disease monitoring in newly-diagnosed glioblastoma. Acta Neuropathol Commun. 2020 Nov 4;8(1):179. doi: 10.1186/s40478-020-01057-7.
PubMed 33148330
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Platelet Level During Radiotherapy Associated With Temozolomide in Patients Treated for Glioblastoma
- ClinicalTrials.gov ID
- NCT02617745
- Acronym / sponsor ID
- GLIOPLAK / CHB 15.02
- Conditions
- Glioblastoma
- Keywords
- Stupp protocol, glioblastoma, thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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.
The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed.
Detailed description
Glioblastoma is the most common primitive cerebral tumor. Currently its optimal treatment is based on a multidisciplinary approach combining an initial surgical resection, if feasible, then Stupp protocol. Stupp protocol consists of two phases: first phase involves external radiotherapy with concomitant oral temozolomide at a dose of 75mg/m2 per day for about six weeks. After 4 weeks of therapy break, maintenance phase begins with temozolomide alone, for a period of 6 cycles (1 cycle = 5 days over 28). The dose of temozolomide is 150mg/m2 on the first cycle followed by 200 mg/m2. One major limiting toxicity of temozolomide is hematologic, especially thrombocytopenia. They occur in around 15 and 20% of patients in maintenance phase. Thrombocytopenia has an impact on the schedule of Stupp protocol such as dose reduction or even early discontinuation. Currently no predictive marker of thrombocytopenia in the maintenance phase was identified. Such marker could be of major interest to adapt biological and clinical follow-up by patient in maintenance phase. We conduct a retrospective analysis on a cohort of patients suffering from glioblastoma and treated with Stupp protocol. We found that a decrease in platelet count during the radio-chemotherapy phase could be highly predictive of protocol changes in maintenance phase of temozolomide due to thrombocytopenia. The main objective of GLIOPLAK is to prospectively confirm the predictive value of this test and to evaluate the prognostic impact of the occurrence of thrombocytopenia <100,000/mm3. Secondary objective of GLIOPLAK are to describe all limiting toxicities in maintenance phase, to constitute a prospective biological collection and to collect biological samples to perform pharmacological analysis (pharmacogenomics and pharmacokinetics parameters).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stupp protocol | Experimental | Other: Platelet level determinationBlood assessment of the platelet level every week during the radiotherapy phase and every cycle during the chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age Superior to 18 years
- Inform consent form signed
- Newly diagnosed (histologically) glioblastoma
- Stupp protocol treatment
- with social insurance
Key exclusion criteria (5 listed)
- Not inform consent form signed
- participation to another clinical trial
- other cancer
- background of hematological pathology
- patient under guardianship, curatorship
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 |
|---|---|---|
| Platelet level determinationevaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. For this the platelet level will be determined each wek during the radiotherapy phase and each cycle during the chemotherapy phase | Other | Stupp protocol |
Primary outcome
Number of time where platelet level was Under 100 000 per mm3
Time frame: one year and 6 months
Determination of platelet level to predict the risk of thrombocytopenia
2 secondary outcomes
Overall survival
Time frame: 3 years
Therapeutic modifications
Time frame: one year and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 39394177Fontanilles M, Heisbourg JD, Daban A, Di Fiore F, Pepin LF, Marguet F, Langlois O, Alexandru C, Tennevet I, Ducatez F, Pilon C, Plichet T, Mokbel D, Lesueur C, Bekri S, Tebani A. Metabolic remodeling in glioblastoma: a longitudinal multi-omics study. Acta Neuropathol Commun. 2024 Oct 12;12(1):162. doi: 10.1186/s40478-024-01861-5.
- Derived from this study: PubMed 38340682Daban A, Beaussire-Trouvay L, Leveque E, Alexandru C, Tennevet I, Langlois O, Veresezan O, Marguet F, Clatot F, Di Fiore F, Sarafan-Vasseur N, Fontanilles M. Prognostic value of circulating short-length DNA fragments in unresected glioblastoma patients. Transl Oncol. 2024 Apr;42:101897. doi: 10.1016/j.tranon.2024.101897. Epub 2024 Feb 9.
- Derived from this study: PubMed 33148330Fontanilles M, Marguet F, Beaussire L, Magne N, Pepin LF, Alexandru C, Tennevet I, Hanzen C, Langlois O, Jardin F, Laquerriere A, Sarafan-Vasseur N, Di Fiore F, Clatot F. Cell-free DNA and circulating TERT promoter mutation for disease monitoring in newly-diagnosed glioblastoma. Acta Neuropathol Commun. 2020 Nov 4;8(1):179. doi: 10.1186/s40478-020-01057-7.
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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.
Frederic Di Fiore, MD, PhD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet level determination in people with Glioblastoma, run by Centre Henri Becquerel at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of time where platelet level was Under 100 000 per mm3 (time frame: one year and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617745, which also lists 3 linked publications.
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 2 Jan 2026.