NCT03663725

Brief Summary

Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P50-P75 for phase_3

Timeline
14mo left

Started Mar 2019

Longer than P75 for phase_3

Geographic Reach
1 country

17 active sites

Status
active not recruiting

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

Study Progress86%
Mar 2019Jun 2027

First Submitted

Initial submission to the registry

September 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

March 13, 2019

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

8.2 years

First QC Date

September 4, 2018

Last Update Submit

March 25, 2026

Conditions

Glioblastoma

Keywords

temozolomideStupp protocol

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    time interval from randomization to death whatever the cause

    up to 18 months after recruitment of the last patient

Secondary Outcomes (2)

  • Number of adverse events

    up to 18 months after recruitment of the last patient

  • Progression-free survival

    up to 18 months after recruitment of the last patient

Study Arms (2)

Intensified protocol

EXPERIMENTAL

Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ

Drug: Intensified protocol

Stupp protocol

ACTIVE COMPARATOR

Concomitant Temozolomide (TMZ) Adjuvant TMZ

Drug: Stupp protocol

Interventions

Intensified protocolDRUG

Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)

Intensified protocol
Stupp protocolDRUG

RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ

Stupp protocol

Eligibility Criteria

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

You may qualify if:

  • Patient ≥18 years old
  • Histological diagnosis of de novo GBM (extemporaneous diagnosis or standard pathological examination). In case of extemporaneous diagnosis, the patient can be included. If the diagnosis is not confirmed, the patient will be withdrawn from study.
  • Time between initial surgery/biopsy and planned start of treatment (if allocated to the experimental arm) ≤ 15 days (ideally in the first 7 days)
  • Karnofsky performance status (KPS) ≥ 60%, or KPS \<60% only related to glioma-related motor paresis.
  • Adequate biological functions
  • Common toxicity criteria (CTC) non hematological adverse events ≤ Grade 1 (except for alopecia, nausea, vomiting and neurological symptoms)
  • Females of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Sexually active patients must agree to use adequate and appropriate contraception while on study drug and for 6 months after stopping the study drug.
  • Standard radiation therapy deemed feasible (60 Gy, 30 fractions)
  • Time interval of less than 43 days between initial surgery/biopsy and planned start of radiation therapy
  • Written informed consent

You may not qualify if:

  • Secondary or recurrent glioblastoma (GBM)
  • Planned use of tumor-treating electric fields
  • Planned use of Carmustine implants
  • Severe myelosuppression
  • Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC)
  • Known current viral hepatitis, HIV infection or current active infectious disease
  • Inability to swallow oral medications or any mal-absorption condition
  • Pregnant or breastfeeding patients.
  • Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
  • Person under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Centre Hospitalier d'Amiens

Amiens, 80054, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

CHU de Limoges

Limoges, 87042, France

Location

Centre Léon Bérard

Lyon, 69673, France

Location

CHU La Timone

Marseille, 13385, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

CHRU Nancy

Nancy, 54000, France

Location

CHU de Nice - Hôpital de Cimiez

Nice, 06000, France

Location

APHP La Pitié Salpêtrière

Paris, 75013, France

Location

CH René Dubos

Pontoise, 95300, France

Location

Institut Cancérologie Loire

Saint-Priest-en-Jarez, 42270, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

CHRU Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Florence LEFRANC, MD

    ERASME

    PRINCIPAL INVESTIGATOR

  • Bruno CHAUFFERT, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 10, 2018

Study Start

March 13, 2019

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(17)