NCT00466089Unknown2 期
Phase II Randomized Trial of 3D Radiotherapy Versus the Combination of 3D Radiotherapy and Erlotinib (Tarceva®) in Patients With Localized-Unresectable Non-Small Cell Lung Cancer Non Susceptible for Chemotherapy Treatment.
Hospital of Navarra5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
研究概览
简要总结
A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent prior to any specific procedure of the protocol.
- •Histologically confirmed diagnosis of non small cell lung cancer.
- •Unresectable (IA-IIIB) non-small cell lung cancer.
- •Patients non susceptible for chemotherapy treatment
- •Measurable disease according to RECIST criteria
- •Age > 18 years.
- •ECOG performance status <
- •Adequate bone marrow, hepatic, renal and respiratory function.
- •Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up.
- •Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment.
- •Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.
排除标准
- •Prior chemotherapy or radiotherapy.
- •History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
- •Pregnant or lactating women.
- •Any other severe disease or clinical conditions, as, but not only:
- •Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
- •Uncontrolled active infection
- •Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
- •Autoimmune diseases.
- •Concomitant treatment with any other antineoplastic therapy.
- •Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
- •Prior treatment with EGFR targeted therapies.
- •Erlotinib known hypersensibility.
- •Any radiotherapy treatment contraindication.
- •History of significant neurological or psychiatric disorders, including epileptic seizures.
- •Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended)
- •Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
- •Any other underlying severe process affecting the ability to take part in the study.
研究组 & 干预措施
1
Experimental
RT + Tarceva
干预措施: Erlotinib (Tarceva®) (Drug)
结局指标
主要结局
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
次要结局
- Overall survival.
- The progression-free survival.
- 1-year survival.
- Objective response rate, according to RECIST criteria.
研究者
研究点 (5)
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