cropped color_logo_with_background.png

Treatment Intensification With Temozolomide in Adults With a Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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.

Exclusion Criteria:

  • - Secondary or recurrent glioblastoma (GBM) - Planned use of tumor-treating electric fields.
  • - Planned use of Carmustine implants.
  • - Prior malignancy in the last 5 years before inclusion or concomitant.
  • - Severe myelosuppression.
  • - Known hypersensitivity to any of the study drugs, study drug classes, excipients in the formulation or to dacarbazine (DTIC) - Current or recent treatment with another experimental drug or patients included in a clinical therapeutic trial (in the 30 days prior to inclusion).
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03663725
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Oscar Lambret
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Florence LEFRANC, MDBruno CHAUFFERT, MD
Principal Investigator Affiliation ERASMECHU Amiens
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: Intensified protocol

Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ

Active Comparator: Stupp protocol

Concomitant Temozolomide (TMZ) Adjuvant TMZ

Interventions

Drug: - Intensified protocol

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)

Drug: - Stupp protocol

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Hospitalier d'Amiens, Amiens, France

Status

Recruiting

Address

Centre Hospitalier d'Amiens

Amiens, , 80054

Site Contact

BOONE Mathieu, MD, PhD

[email protected]

33320295918

ICO Centre Paul Papin, Angers, France

Status

Withdrawn

Address

ICO Centre Paul Papin

Angers, , 49055

Centre François Baclesse, Caen, France

Status

Recruiting

Address

Centre François Baclesse

Caen, , 14076

Site Contact

Iona HRAB, MD

[email protected]

33320295918

Centre Jean Perrin, Clermont-Ferrand, France

Status

Recruiting

Address

Centre Jean Perrin

Clermont-Ferrand, , 63011

Site Contact

Xavier DURANDO, MD

[email protected]

33320295918

Hôpitaux Civils de Colmar, Colmar, France

Status

Recruiting

Address

Hôpitaux Civils de Colmar

Colmar, , 68024

Site Contact

Guido AHLE, MD

[email protected]

33320295918

Centre Georges François Leclerc, Dijon, France

Status

Recruiting

Address

Centre Georges François Leclerc

Dijon, , 21079

Site Contact

François GHIRINGELLI, MD, PhD

[email protected]

33320295918

CHU Grenoble Alpes, Grenoble, France

Status

Recruiting

Address

CHU Grenoble Alpes

Grenoble, , 38043

Site Contact

Julien PAVILLET, MD

[email protected]

33320295918

CHU de Limoges, Limoges, France

Status

Recruiting

Address

CHU de Limoges

Limoges, , 87042

Site Contact

Elise DELUCHE, MD

franç[email protected]

33320295918

Centre Léon Bérard, Lyon, France

Status

Recruiting

Address

Centre Léon Bérard

Lyon, , 69673

Site Contact

Alice BONNEVILLE-LEVARD, MD

[email protected]

33320295918

CHU La Timone, Marseille, France

Status

Recruiting

Address

CHU La Timone

Marseille, , 13385

Site Contact

Olivier CHINOT, MD

[email protected]

33320295918

ICM Val d'Aurelle, Montpellier, France

Status

Recruiting

Address

ICM Val d'Aurelle

Montpellier, , 34298

Site Contact

Michel FABBRO, MD, PhD

[email protected]

33320295918

CHRU Nancy, Nancy, France

Status

Recruiting

Address

CHRU Nancy

Nancy, , 54000

Site Contact

Luc TAILLANDIER, MD

[email protected]

33320295918

ICO Centre René Gauducheau, Nantes, France

Status

Withdrawn

Address

ICO Centre René Gauducheau

Nantes, , 44805

CHU de Nice - Hôpital de Cimiez, Nice, France

Status

Recruiting

Address

CHU de Nice - Hôpital de Cimiez

Nice, , 06000

Site Contact

Véronique BOURG, MD

[email protected]

33320295918

APHP La Pitié Salpêtrière, Paris, France

Status

Recruiting

Address

APHP La Pitié Salpêtrière

Paris, , 75013

Site Contact

Khe HOANG XUAN, MD

[email protected]

33320295918

CH René Dubos, Pontoise, France

Status

Recruiting

Address

CH René Dubos

Pontoise, , 95300

Site Contact

Claudia RIZZO, MD

[email protected]

33320295918

Institut Cancérologie Loire, Saint-Priest-en-Jarez, France

Status

Recruiting

Address

Institut Cancérologie Loire

Saint-Priest-en-Jarez, , 42270

Site Contact

Carole RAMIREZ, MD

[email protected]

33320295918

Centre Paul Strauss, Strasbourg, France

Status

Recruiting

Address

Centre Paul Strauss

Strasbourg, , 67065

Site Contact

Roland SCHOTT, MD

[email protected]

33320295918

CHRU Tours, Tours, France

Status

Recruiting

Address

CHRU Tours

Tours, , 37044

Site Contact

Ilyess ZEMMOURA, MD

[email protected]

33320295918