Bone Metastatic Non-Small Cell Lung Cancer
Conditions
Interventions
Group A:vinorelbine 25mg/? d1,8+ Cisplatin 80mg/? d1 every 21days * 2 cycles
Group B:vinorelbine 25mg/? d1,8+ Cisplatin 80mg/? d1 + endostatin 7.5mg/? d1-14, every 21days * 2 cycles
Sponsors
Shanghai Sixth People's Hospital Affiiliated to Shanghai JiaoTong University
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. NSCLC patients with adenocarcinoma, Squamous carcinoma, large cell carcinoma, adenosquamous carcinoma or mixed carcinoma conformed by pathology; 2. Patients whose clinical stage is IV; 3. Patients who has not received taxanes, bevacizumab, thalidomide, endostatin or bisphosphonates treatment in the recent 12 weeks; 4. Patients whose age is between 18 and 75 years, ECOG status 0 to 2; KPS >=60; Life expectancy >3 months; 5. Patients without important organ dysfunction and with normal bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range. Some special are listed below: White blood cell(WBC) >= 4.0*10^9/L Neutrophil >=2.0*10^9/L; platelets count >=100*10^9/L; Total bilirubin 1.0 cm by MRI and/or CT exam; (2) with bone metastasis lesions can be measured by MRI(without contraindicated metallic device or metallic fragments); 8. The bone lesions to be measured have not received radiotherapy or other prior local therapy; 9. Patients with good compliance to the treatment and follow-up and have the ability to understand and the willingness to sign a written informed consent form;* means mixed of adenocarcinoma, Squamous carcinoma, large cell carcinoma, adenosquamous carcinoma.
Exclusion criteria
Exclusion criteria: 1. without the evidence of bone metastasis; 2. Patients who has received taxanes, bevacizumab, thalidomide, endostatin or bisphosphonates treatment in the recent 12 weeks; risk of agents used in trial or effect the result of trial, judged by researchers; 3. Patients with any acute or chronic disease or or mental status, which may increase the congestive heart failure or uncontrollable arrhythmia in the last 12 months (defined as New Uncontrollable hypertension, unstable angina, myocardial infarction or symptomatic Myocardial ischemia hinted by EKG or cardiac valve disease with definite clinical York Heart Association Class II or greater); diagnosis Active stage of infection by bacterium, eumycete or virus 4. Patients who is pregnant or breastfeeding; 5. Patients with other malignant tumor besides NSCLC, except skin cancer (not Melanoma), in situ Cervical Cancer and been cured early stage prostate cancer; 6. Patients who is or is suspected to hypersensitivity to any agents to be used during the trial, including gadolinium-containing MR contrast agents; 7. Patients without good compliance; 8. Patients considered by researcher not suitable to participate this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactHui Zhao
Outcome results
None listed