2024-517480-23-00招募中2 期
The asssessment of the efficacy of induction radiochemotherapy using low doses of ionizing radiation (iCHRTL) in the treatment of patients with advanced throat and larynx cancer
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月9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
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate after induction assessment (ORR)
研究概览
简要总结
-evaluation of the efficacy of iCHRTL in patients with advanced cancer of the throat or larynx -assessment of iCHRTL tolerance in patients with advanced cancer of the throat or larynx -evaluation of the molecular and biochemical effect of low doses of ionizing radiation
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
- 否
入选标准
- •Patients with advanced cancer of the upper, middle, lower throat or laryngeal cancer not previously treated for this
- •Severity of the disease: N1> 2 cm, N2, N3; T2, T3, T4, M0
- •Patient eligible for radical treatment with induction chemotherapy (general condition at least good, no significant additional conditions disqualifying from induction chemotherapy)
- •Signed informed consent to participate in the study
- •≥ 18 years of age
排除标准
- •Known or suspected hypersensitivity to any of the investigational drugs
- •Hepatitis B virus (HBV) infection defined as a positive test for HBsAg. In addition, in the case of a negative HBsAg test result, but a positive HBcAb test result (regardless of HBsAb status), HBV DNA testing should be performed and in the case of a positive result, the patient cannot be included in the trial
- •Hepatitis C virus (HCV) infection defined as a positive HCAb test, in which case an HCV RIBA immunoblot test from the same sample should be performed to confirm the result
- •Pregnancy or breastfeeding (women of childbearing age should undergo a pregnancy test at screening)
- •Women of childbearing potential, including those with their last menstrual period less than one year prior to screening, who are unable or unwilling to use adequate contraception methods from the beginning of the study to six months after the last intake dose of the study drug. Adequate contraception is defined as use of oral hormonal contraceptives, intrauterine device, double barrier method, or sexual abstinence
- •Men who are unable or unwilling to use adequate contraceptive methods from the start of the study to six months after taking the last dose of study medication
- •Patients unable or unwilling to adhere to the study protocol.
- •Baseline values for the following parameters (during the screening phase): -Creatinine> 2.0 times upper limit of normal (unless creatinine clearance is normal); - Total bilirubin> 1.5 times the upper limit of normal (except for hyperbilirubinemia due to Gilbert's syndrome); - ALT > 2.5 times the upper limit of normal; - Alkaline phosphatase activity> 2.5 times the upper limit of normal
- •First treatment with any unauthorized drug or experimental treatment within 5 half-lives of this substance or 4 weeks prior to enrollment in a study (longer period must be taken), or currently enrollment in other interventional clinical trials
- •Coexistence of another neoplasm or a history of neoplastic disease with a significant potential influence on the tolerability or efficacy of iCHRTL
- •Chronic or active infection requiring the use of antibiotics, antifungal medications, or antiviral medications, such as, but not limited to, chronic kidney infection, chronic bronchospastic respiratory infection, tuberculosis, or active hepatitis C
- •Significant history of cerebrovascular disease within 6 months or current symptomatic or sequelae
- •HIV infection
- •Clinically significant heart disease including unstable angina, myocardial infarction in the 6 months prior to study entry, severe NYHA III-IV congestive heart failure, arrhythmias, unless treatable, except for extrasystole or minimal contractions conduction disturbances
- •Significant co-morbidities that are untreatable, such as, but not limited to, kidney, liver, gastrointestinal, endocrine, respiratory, neurological, brain, and mental illness that the investigator believes may pose a risk to the patient
结局指标
主要结局
Objective response rate after induction assessment (ORR)
Objective response rate after induction assessment (ORR)
Local and nodal healing rate assessement (LRC)
Local and nodal healing rate assessement (LRC)
Assessment of iCHRTL tolerance in patients with advanced cancer of the throat or larynx - the frequency of side effects by system
Assessment of iCHRTL tolerance in patients with advanced cancer of the throat or larynx - the frequency of side effects by system
次要结局
- Distant metastases rate assessment
- Overall survival assessment
- Evaluation of the molecular and biochemical effect of low doses of ionizing radiation
- Relapse free survival (RFS) assessment
- Progression free survival (PFS) assessment
研究者
Prof. Tomasz Rutkowski
Scientific
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
研究点 (1)
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