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

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: Active, not recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Other: Platelet level determination

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

• Study Contact: Name: Frederic Di Fiore, MD, PhD; Phone Number: +33232082554; Email: frederic.difiore@chb.unicancer.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of Arms

1

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	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 between inclusion and death	3 years
Therapeutic modifications	Proportion of patient with treatment modifications	one year and 6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Fontanilles 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2015
• Primary Completion (Actual): November 28, 2022
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: November 26, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Stupp protocol, glioblastoma, thrombocytopenia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: CHB 15.02