Intensified treatment with temozolomide for adults with glioblastoma
Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
This study is testing whether a more intense treatment with temozolomide can help adults with glioblastoma do better than the usual treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 486 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Oscar Lambret Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 19 sites (Amiens and 18 other locations) |
| Trial ID | NCT03663725 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares an intensified treatment approach using temozolomide (TMZ) for adults diagnosed with glioblastoma to the standard EORTC regimen. Participants will be randomized to receive either early TMZ and extended adjuvant TMZ until toxicity, progression, or patient refusal, or the classical regimen of radiotherapy followed by a limited number of adjuvant TMZ cycles. The goal is to determine the optimal timing and duration of TMZ therapy to improve patient outcomes. The trial aims to address conflicting data regarding the best approach to chemotherapy in glioblastoma treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of de novo glioblastoma and adequate performance status.
Not a fit: Patients with a diagnosis of glioblastoma that is not confirmed or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with glioblastoma.
How similar studies have performed: Other studies have shown varying results with similar approaches, but this trial aims to clarify the optimal treatment strategy for glioblastoma.
Eligibility criteria
Show full 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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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
Where this trial is running
Amiens and 18 other locations
- Centre Hospitalier d'Amiens — Amiens, France (Recruiting)
- ICO Centre Paul Papin — Angers, France (Withdrawn)
- Centre François Baclesse — Caen, France (Recruiting)
- Centre Jean Perrin — Clermont-Ferrand, France (Recruiting)
- Hôpitaux Civils de Colmar — Colmar, France (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Recruiting)
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
- CHU de Limoges — Limoges, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- CHU La Timone — Marseille, France (Recruiting)
- ICM Val d'Aurelle — Montpellier, France (Recruiting)
- CHRU Nancy — Nancy, France (Recruiting)
- ICO Centre René Gauducheau — Nantes, France (Withdrawn)
- CHU de Nice - Hôpital de Cimiez — Nice, France (Recruiting)
- APHP La Pitié Salpêtrière — Paris, France (Recruiting)
- CH René Dubos — Pontoise, France (Recruiting)
- Institut Cancérologie Loire — Saint-Priest-en-Jarez, France (Recruiting)
- Centre Paul Strauss — Strasbourg, France (Recruiting)
- CHRU Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Florence LEFRANC, MD — Erasme
- Study coordinator: Marie VANSEYMORTIER
- Email: promotion@o-lambret.fr
- Phone: 33320295918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.