2023-505267-36-00招募中3 期
EORTC 2227-BTG: Lomustine with or without reirradiation for first progression of glioblastoma: a randomized phase III study (LEGATO)
European Organisation For Research And Treatment Of Cancer, European Organisation For Research And Treatment Of Cancer40 个研究点 分布在 10 个国家目标入组 399 人开始时间: 2024年2月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 399
- 试验地点
- 40
- 主要终点
- The primary endpoint is OS defined as the number of days from date of enrolment to the date of death due to any cause.
研究概览
简要总结
The primary objective is to show that overall survival (OS) with lomustine plus reirradiation is superior compared to lomustine monotherapy for first progression of glioblastoma
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Before patient’s enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to enrolment
- •Candidates for treatment with lomustine as per physician’s assessment.
- •Patients of childbearing / reproductive potential must agree to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of study treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
- •Patients with first progression or recurrent glioblastoma after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy with recurrence occuring at least 6 months after the end of Prior radiotherapy Prior first line therapy may include: Any systemic antineoplastic treatment other than nitroureas , Tumour-treating fields, Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
- •Measurable disease according to RANO criteria with a maximum tumour diameter of 5 cm (local investigator assessment) Note 1: in case of multiple lesions, maximum cumulative CTV diameter of 5 cm treatable by 1 isocentre. Note 2: in case of surgery for recurrence, this criterion applies at the time of recurrence.
- •In case of surgery for recurrence: fully recovered from surgery, confirmation of recurrence by histology, and patient fit for treatment as per local investigator assessment. Note: residual and measurable disease after surgery is not required, provided that measurable disease was present before surgery.
- •Histologically proven diagnosis of glioblastoma, IDH wildtype per WHO 2021 classification and local assessment of tissue from diagnosis or recurrence
- •Stable or decreasing dose of steroids for 7 days prior to enrolment
- •Age ≥ 18 years
- •WHO Performance status of 0-2
排除标准
- •Any prior anticancer treatment for recurrent glioblastoma (except surgery)
- •Any serious or uncontrolled medical condition (e.g., infections, chronic alcoholism, drug addiction) or abnormality, in the judgment of the investigator that prohibits obtaining informed consent, safe participation and study completion
- •Known contraindication to imaging tracer or any product of contrast media and Magnetic Resonance Imaging (MRI) contraindications
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
- •Concurrent or recent history (30 days prior to lomustine initiation) of varicella (infection or exposure) and herpes zoster
- •Known hereditary galactose intolerance, Lapp-lactase deficiency, or glucose-galactose malabsorption.
- •Patients with known pulmonary infiltration, interstitial pneumonia or pulmonary fibrosis and with a baseline below 70% of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DLCO)
- •Significant reduction in thrombocyte and/or leukocyte counts (leukocytes < 4 x 10^9 /L and the platelets < 100 x 10^9 /L) as well as severe renal impairment according to investigator's opinion
- •History or present acute leukaemia or any myeloid disease
- •Known hypersensitivity to the active components or excipients of lomustine
- •Known coeliac disease or wheat allergy
- •Live attenuated vaccine in the 3 months prior to lomustine initiation
结局指标
主要结局
The primary endpoint is OS defined as the number of days from date of enrolment to the date of death due to any cause.
The primary endpoint is OS defined as the number of days from date of enrolment to the date of death due to any cause.
次要结局
- PFS. Events are progressions based on Response Assessment in Neuro Oncology (RANO) criteria as determined by the local investigator
- Objective and complete response per RANO criteria as assessed by the local investigator
- Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting
- QDFS. A deterioration event is defined as ≥10-point worsening from baseline in the GHQ without further improvement (i.e., no subsequent ≥10 point improvement) or death due to any cause
- Neurocognitive functioning assessed by Mini Mental State Examination (MMSE).
- Health utility, calculated from the collected patient-reported HRQoL data from the QLQ-C30 and patient demographics
- Change scores. Changes in HRQoL from baseline in the GHQ/QoL, fatigue, nausea/vomiting, physical, role and social functioning scale scores assessed over time will be evaluated descriptively. Descriptive summaries such as median, range (minimum, maximum), IQR, mean and standard deviation will be provided for all the other scales from the QLQ-C30, QLQ-BN20 and the item list (IL46).
研究者
Stephanie Kromar
Scientific
European Organisation For Research And Treatment Of Cancer
研究点 (40)
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