2024-517832-23-00招募中2 期
Prospective, multicentre phase II study of de-escalation of primary chemoradiotherapy of squamous cell carcinoma of oropharynx (OPC) associated with human papilloma virus (HPV)
Vychodoslovensky Onkologicky Ustav a.s.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月4日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Two-year locoregional control
研究概览
简要总结
Assesment of primary CRT de-escalation effectiveness in achieving two-year local disease control and late toxicity prevalence evaluated by CTC AE v.4 and PRO CTC v 4.
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
- •Oropharyngeal squamous cell carcinoma
- •Neutrophils ≥ 1,5 x 10x9/l
- •Adequate renal functions enable one-week therapy of cisplatina
- •Bilirubin, AST or ALT 3x upper limit of norm
- •Negative pregnancy test
- •Signed informed consent
- •Slovak language
- •Positivity of p16 by imunohistochemistry
- •Clinical stage T1-T2, N1-N2c or T3, N2-N2c, UICC 8th edition without distant metastases
- •The lifetime cumulative history of smoking cannot exceed 20 packages / years
- •WHO status 0-1
- •Age ≥ 18 years
- •Both genders
- •Hemoglobin ≥ 10 g/l
- •Platelets ≥1 00x 10x9/l
排除标准
- •Tumor in the oral cavity or in nasopharynx or in the hypopharynx or larynx if the p16 is also positive
- •Hepatic insufficiency with clinical jaundice and impaired coagulation
- •Active AIDS disease, but the protocol does not require HIV testing
- •Previous allergic reaction to cisplatin
- •Tumor of unknown origin (p16 positivity too)
- •Simultaneous tumors
- •Patients with invasive malignancy (except non-melanoma skin cancer) and a history of tumor diagnosis less than 3 years
- •Previous radiotherapy in the head and neck area to overlap the irradiated volume
- •Unstable angina or congestive heart failure requiring hospitalization for the last 6 months
- •Transmural myocardial infarction last 6 months
- •Active infection requiring i.v. antibiotics at the time of registration
- •Chronic obstructive bronchoplumonal disease with exacerbation or other respiratory disease requiring hospitalization or postponement of study treatment within 30 days of enrollment
结局指标
主要结局
Two-year locoregional control
Two-year locoregional control
次要结局
- Primary loco-regional control after initial intervention and CRT
- Overall survival
- Disease-specific survival
- Survival without disease
- Percentage of distant metastases
- Adverse effects
- Influencing QoL
- Reliability and validity of biomarker p16
- Difference in OPC-associated HPV molecular profile in non-smokers and smokers
研究者
Principal investigator
Scientific
Vychodoslovensky Onkologicky Ustav a.s.
研究点 (1)
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