NCT03663725招募中3 期
Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 486
- 试验地点
- 38
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 If the diagnosis is not confirmed, the patient will be withdrawn from study.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
排除标准
- •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
研究组 & 干预措施
Intensified protocol
Experimental
Early Temozolomide (TMZ) Concomitant TMZ Adjuvant TMZ Prolonged TMZ
干预措施: Intensified protocol (Drug)
Stupp protocol
Active Comparator
Concomitant Temozolomide (TMZ) Adjuvant TMZ
干预措施: Stupp protocol (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: up to 18 months after recruitment of the last patient
time interval from randomization to death whatever the cause
次要结局
- 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)
研究者
研究点 (38)
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