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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02617745
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : July 30, 2020
Information provided by (Responsible Party):
Centre Henri Becquerel

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Other: Platelet level determination Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of the Platelet Level During Radiotherapy Associated With Temozolomide in Patients Treated for Glioblastoma
Actual Study Start Date : November 30, 2015
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    time between inclusion and death

  2. Therapeutic modifications [ Time Frame: one year and 6 months ]
    Proportion of patient with treatment modifications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02617745

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Contact: Frederic Di Fiore, MD, PhD +33232082554
Contact: Doriane Richard, PhD +33232082985

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Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Frederic Di Fiore, MD, PhD    +33232082554   
Contact: Doriane Richard, PhD    +33232082985   
Sub-Investigator: Isabelle Tennevet, MD         
Sub-Investigator: Cristina Alexandru, MD         
Sub-Investigator: Ovidiu Veresezan, MD         
Sub-Investigator: Chantal Hanzen, MD         
Sub-Investigator: Bernard Dubray, MD, PhD         
Sponsors and Collaborators
Centre Henri Becquerel
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Principal Investigator: Frederic Di Fiore, MD, PhD Centre Henri Becquerel
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Henri Becquerel Identifier: NCT02617745    
Other Study ID Numbers: CHB 15.02
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Keywords provided by Centre Henri Becquerel:
Stupp protocol, glioblastoma, thrombocytopenia
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue