Impact of the Platelet Level in Patients Treated for Glioblastoma With Temozolomid (GLIOPLAK)

December 29, 2025 updated by: Centre Henri Becquerel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

244

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76038
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age Superior to 18 years
  • Inform consent form signed
  • Newly diagnosed (histologically) glioblastoma
  • Stupp protocol treatment
  • with social insurance

Exclusion Criteria:

  • Not inform consent form signed
  • participation to another clinical trial
  • other cancer
  • background of hematological pathology
  • patient under guardianship, curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stupp protocol
Blood assessment of the platelet level every week during the radiotherapy phase and every cycle during the chemotherapy
Other: Platelet level determination
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
time between inclusion and death
3 years
Therapeutic modifications
Time Frame: one year and 6 months
Proportion of patient with treatment modifications
one year and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Frederic Di Fiore, MD, PhD, Centre Henri Becquerel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2015

Primary Completion (Actual)

November 28, 2022

Study Completion (Actual)

June 5, 2024

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimated)

December 1, 2015

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB 15.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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