2022-502339-20-00已完成2 期
EORTC 2120-HNCG: Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study (Ravina)
European Organisation For Research And Treatment Of Cancer23 个研究点 分布在 9 个国家目标入组 225 人开始时间: 2023年7月25日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 23
- 主要终点
- The primary endpoint is locoregional event-free survival (LREFS) as assessed by the local investigator. Events are defined as locoregional progression, recurrence of locoregional disease, new SCC of the head and neck in the radiation field and death from any cause.
研究概览
简要总结
The primary objective is to assess the benefit of adding xevinapant to RT in terms of duration of locoregional event-free survival (LREFS) in older patients with LA-HNSCC
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years.
- •Written informed consent must be signed according to ICH/GCP, and national/local regulations
- •Pathologically proven new diagnosis of HNSCC of oral cavity, oropharynx, hypopharynx and larynx tumour.
- •cT3-4 cN0 cM0 or cT1-4 cN1-3 cM0 except for cT1-2 cN1 p16 positive oropharyngeal cancer (AJCC 8th edition).
- •HPV status using p16 immunohistochemistry (IHC) available for oropharyngeal squamous cell carcinoma.
- •Measurable disease per RECIST 1.
- •Intention to treat with curative intent primary radiotherapy alone.
- •Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy or jejunostomy placed.
- •Adequate hematologic, renal, and hepatic function as indicated by: • Creatinine clearance ≥ 30 mL/min, measured with the Cockroft and Gault formula. • Absolute neutrophil count ≥ 1 500 cells/μL. • Platelets ≥ 100 000 cells/μL. • Hemoglobin ≥ 9.0 g/dL or ≥5.6 mmol/L (blood transfusions during screening are permitted). • AST and ALT ≤ 3.0 × upper limit of normal (ULN). • Total bilirubin ≤ 1.5 × ULN (up to 2.0 × ULN is allowed, if the direct bilirubin level is normal and the elevation is limited to indirect bilirubin).
排除标准
- •Unknown primary, primary nasopharynx and paranasal sinus
- •Any uncontrolled, intercurrent illness or clinical situation that would in the judgment of investigator, limit compliance with study requirements. This includes but is not limited to uncontrolled active infections, defined as any infection requiring IV antibiotics within 7 days prior to enrolment.
- •Two primaries.
- •Any previous or current treatment for invasive head and neck cancer, including induction chemotherapy, surgery, concomitant chemotherapy and cetuximab.
- •Gastrointestinal disorders that could affect drug absorption.
- •Another malignancy in the previous 3 years with exception of curatively treated disease with no evidence of recurrence.
- •Known allergy to xevinapant or any excipient known to be present in active or placebo formulation.
- •Active gastrointestinal bleeding, or any other uncontrolled bleeding requiring more than 2 red blood cell transfusions or 4 units of packed red blood cells within 4 weeks prior to enrolment
- •Decompensated or symptomatic liver cirrhosis (Child-Pugh score: B or C)
- •Impaired cardiovascular function or clinically significant cardiovascular diseases
研究组 & 干预措施
xevinapant
Experimental
Participants receiving xevinapant
干预措施: xevinapant (Drug)
结局指标
主要结局
The primary endpoint is locoregional event-free survival (LREFS) as assessed by the local investigator. Events are defined as locoregional progression, recurrence of locoregional disease, new SCC of the head and neck in the radiation field and death from any cause.
The primary endpoint is locoregional event-free survival (LREFS) as assessed by the local investigator. Events are defined as locoregional progression, recurrence of locoregional disease, new SCC of the head and neck in the radiation field and death from any cause.
次要结局
- Response to treatment according to RECIST 1.1
- Progression Free Survival as assessed by the local investigator.
- Overall Survival
- Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting
- Patient-reported HRQoL as assessed by global health/QoL and physical functioning scales from the EORTC QLQ-C30 at week 20. The fatigue scale from the QLQ-C30, and pain in the head and neck scale from IL225 will be assessed to provide additional insight into the treatment effects for the global health/QOL scale (QLQ-C30) and the physical functioning scales
研究者
Stéphanie Kromar
Scientific
European Organisation For Research And Treatment Of Cancer
研究点 (23)
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