NCT00193323已完成2 期
A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 2
- 主要终点
- median survival
研究概览
简要总结
In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.
详细描述
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
Docetaxel Docetaxel + Gemcitabine
For ever 2 patients treated, 1 will receive treatment A (docetaxel) and 1 will receive treatment B (Docetaxel + Gemcitabine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
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
- 是
入选标准
- •To be included in this study, you must meet the following criteria:
- •Biopsy-proven non-small cell lung cancer
- •No previous chemotherapy.
- •Age > 65 years
- •Age < 65 years requires significant assistance to perform activities of daily
- •Stage IV disease or stage IIIB disease
- •Ability to perform activities of daily living with minimal assistance
- •Measurable or evaluable disease
- •Adequate bone marrow, liver and kidney
- •All patients must sign written informed consent prior to study entry.
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Brain metastases
- •Meningeal metastases
- •Other uncontrolled malignancies
- •History of invasive cancer during the last 5 years
- •Moderate to severe peripheral neuropathy
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
median survival
one-year survival.
次要结局
- toxicity
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
3 期
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell TumorsGerminomaMixed Germ Cell TumorYolk Sac TumorChildhood TeratomaMalignant Germ Cell NeoplasmExtragonadal SeminomaGerm Cell TumorNon-seminomatous Germ Cell TumorSeminomaTeratomaChoriocarcinomaNCT02375204Alliance for Clinical Trials in Oncology420
Unknown
3 期
ICON8: Weekly Chemotherapy in Ovarian CancerOvarian CancerNCT01654146Medical Research Council1,485
进行中（未招募）
3 期
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaNeck Squamous Cell Carcinoma of Unknown PrimaryRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Laryngeal Verrucous CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Neck Squamous Cell Carcinoma of Unknown PrimaryRecurrent Oral Cavity Verrucous CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Salivary Gland CarcinomaRecurrent Sinonasal Squamous Cell CarcinomaSalivary Gland Squamous Cell CarcinomaStage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Major Salivary Gland Cancer AJCC v7Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVA Laryngeal Verrucous Carcinoma AJCC v7Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Major Salivary Gland Cancer AJCC v7Stage IVA Oral Cavity Cancer AJCC v6 and v7Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVB Laryngeal Verrucous Carcinoma AJCC v7Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVB Major Salivary Gland Cancer AJCC v7Stage IVB Oral Cavity Cancer AJCC v6 and v7Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7Stage IVC Laryngeal Verrucous Carcinoma AJCC v7Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IVC Major Salivary Gland Cancer AJCC v7Stage IVC Oral Cavity Cancer AJCC v6 and v7Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7Tongue CarcinomaNCT00588770National Cancer Institute (NCI)403
进行中（未招募）
不适用
Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With CancerSolid NeoplasmNCT02517034City of Hope Medical Center600
已完成
3 期
Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic CancerPancreatic CancerNCT01926197Stanford University27