NCT02617745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

November 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

7 years

First QC Date

November 16, 2015

Last Update Submit

December 29, 2025

Conditions

Glioblastoma

Keywords

Stupp protocol, glioblastoma, thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall survival

    3 years

  • Therapeutic modifications

    one year and 6 months

Study Arms (1)

Stupp protocol

EXPERIMENTAL

Blood assessment of the platelet level every week during the radiotherapy phase and every cycle during the chemotherapy

Other: Platelet level determination

Interventions

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

Stupp protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

Related Publications (3)

  • 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.

    PMID: 39394177DERIVED

  • Daban 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.

    PMID: 38340682DERIVED

  • 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.

    PMID: 33148330DERIVED

MeSH Terms

Conditions

GlioblastomaThrombocytopenia

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Frederic Di Fiore, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

December 1, 2015

Study Start

November 30, 2015

Primary Completion

November 28, 2022

Study Completion

June 5, 2024

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

FR(1)