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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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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 3037854, France

Status

Recruiting

Address

Centre Hospitalier d'Amiens

Amiens 3037854, , 80054

Site Contact

BOONE Mathieu, MD, PhD

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