2022-500451-23-00招募中3 期
StrateGlio: Phase III randomised trial evaluating early treatment intensification with temozolomide in adults with a glioblastoma
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 19
- 主要终点
- Overall survival will be defined as time interval from randomization to death whatever the cause. Patients alive will be censored at the date of last news.
研究概览
简要总结
To evaluate the impact of intensification with early Temozolomide ) compared to Stupp standard protocol, in terms of Overall Survival (OS)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient ≥18 years old
- •planned MGMT analysis (results not mandatory at inclusion but must be further reported in the eCRF)
- •Written informed consent from patient or the person of trust (“personne de confiance”)
- •France and Belgium: Patient covered by the French or Belgian “Social Security” regime
- •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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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) ≤ 14 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: neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3 independent of transfusion, serum creatinine ≤ 1.5 times ULN; transaminases (ALAT/ ASAT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN (except in case of Gilbert’s disease)
- •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
排除标准
- •IDH-mutant (IDH1 ou IDH2) astrocytoma (grade 4) or recurrent gliosblastoma (GBM)
- •Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)
- •Person under guardianship or curatorship
- •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.
结局指标
主要结局
Overall survival will be defined as time interval from randomization to death whatever the cause. Patients alive will be censored at the date of last news.
Overall survival will be defined as time interval from randomization to death whatever the cause. Patients alive will be censored at the date of last news.
次要结局
- Adverse events occurring from randomization until disease progression will be reported and graded using the NCI-CTCAE v5.0 classification, including those related to the underlying disease or its progression. All AE will be analyzed, and described according to the reported causal relationship. An AE will be classified as Severe AE if grade is equal or higher than 3 for extra-hematological AE and grade 4 for hematological AE.
- Progression-free survival will be defined as time interval from randomization to the first occurrence of progression according to RANO criteria as assessed by the treating physician, or death whatever the cause. Patients alive without progressive disease will be censored at the date of last news. There will be no central radiological review. The type of progression will be collected (local or peri-local, remotely in the brain, remotely in the meninges)
- Q-TWiST: Quality-adjusted time without symptoms of disease or adverse event
- Exploratory endpoints: Treatment doses will be computed for each treatment component (radiotherapy & chemotherapy), and by treatment phase (early TMZ / concomitant TMZ / adjuvant TMZ). Early administration of TMZ is unlikely to result in leucopenia and/or thrombocytopenia, which could prevent or inhibit conventional concomitant standard dose chemoradiotherapy. It could also lead to platelet transfusions or infections. Patients will be notified. The percentage of deliveries of complete chemoradio
- Total dose of irradiation received and dose-intensity.
- Predictive factors of overall survival: the list of studied factors will be defined later. The methylation of the MGMT promoter is mandatory and will be done in each center. Tumor material will be stored in order to study other biomarkers.
- Description of the post-progression treatments: nature and duration.
研究者
Clinical Research Sponsor Unit
Scientific
Centre Oscar Lambret
研究点 (19)
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