NCT06947668招募中不适用
Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype
研究概览
简要总结
Analysis of tumor tissue (which is already available in pathology) and collection of saliva/stool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated
- •Patients who are cisplatin-unfit for chemotherapy, defined as:
- •Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases
- •Calculated creatinine clearance of ≤50ml/min
- •Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction < 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension
- •Poor nutritional status BMI < 16kg/m²
- •Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.
- •Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes
- •Age ≥ 18 years
- •Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it
排除标准
- •Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion
- •Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)
- •Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment
- •Persistent drug or medication abuse
- •Patients who are unwilling or unable to comply with the protocol and receive treatment
- •Patients who are unsuitable for participation in the study due to a language barrier
研究组 & 干预措施
Treatment group
Patients with squamous cell carcinoma of the head and neck without distant metastases, for whom definitive or postoperative chemoradiation is indicated and who are unfit for cisplatin.
结局指标
主要结局
Determining the feasibility of simultaneous chemoradiotherapy with docetaxel in cisplatin-ineligible patients based on immunophenotype
时间窗: 61 months (duration of entire trial)
次要结局
- Correlation of immunophenotype with overall survival, locoregional control and side effects(61 months (duration of entire trial))
- Identification of patients who will benefit from immunotherapy.(61 months (duration of entire trial))
- Identification of immunological parameters associated with relevant treatment-related complications (e.g. infection, cytopenia)(61 months (duration of entire trial))
研究者
研究点 (1)
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