EUCTR2004-001101-10-GB进行中（未招募）不适用
A prospective, multicenter, randomized phase III study to evaluate the efficacy of Zometa (zoledronic acid) in delaying of progression or recurrences in patients with stage III non-small cell lung cancer
ovartis Pharmaceuticals UK Ltd0 个研究点目标入组 446 人开始时间: 2005年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 446
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Histologically or cytologically confirmed NSCLC(squamous cell carcinoma, adenocarcinoma, large cell carcinoma) NOTE: Mixed tumors with small cell carcinoma and aplastic carcinoma are not eligible
- •Stage IIIA and Stage IIIB at diagnosis excluding patients with pleural effusion at the time of randomisation
- •Patients must hve received the primary treatment for their disease and no progression should have occured
- •Life expectancy of at least 6 months
- •ECOG performance status of 0 or 1
- •Weight loss = 10% in the 6 months before diagnosis of NSCLC
- •Women of childbearing potential must use a medically acceptable form of contraception during the study and must have a negative urine or serum pregnancy test within 7 days of randomisation.
- •Adequate bone marrow reserve defined as white blood cell (WBC) = 3500mm3,
- •neutrophils = 1500 mm3, platelets = 100,000 mm3, Hb = 9 g/dL
- •Able and willing to sign informed consent
- •Patients must have recovered from previous thoracotomy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with NSCLC with pleural effusion at the time of randomisation
- •Patients who received any prior bisphosphonates in past 12 months
- •Presence of metastasis
- •Patients with current malignancy within past 5 years other than NSCLC (exceptions
- •include treated melanoma, ductal carcinoma in situ of the cervix or other cancer cured by resection alone)
- •Thoracotomy = 3 weeks prior to randomization
- •More than 8 months from the start of the primary antitumour treatment
- •Patients with abnormal renal function as evidenced by a calculated creatine clearance < 30ml/minute
- •Current active dental problems including infection of the teech or jawbone (maximilla or mandibular); dental or fixed trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
- •Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- •Corrected serum calcium < 8.0 mg/dL
- •Known hypersensitivity to Zometa or other bisphosphonates
- •Patients with nonmalignant conditions which would confound the evaluation of the
- •primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol,
- •- Uncontrolled infections
- •- Uncontrolled Type 2 Diabetes Mellitus
- •- Diseases with influence on bone metabolism such as Paget’s disease or uncontrolled thyroid or parathyroid dysfunction
- •- Cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which
- •would prevent prolonged follow-up
- •Patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- •Patients in whom the primary antitumor treatment is still ongoing
研究者
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