Lung Cancer
Conditions
Interventions
4:Customized Chemotherapy
Sponsors
Affiliated Drum Tower Hospital to Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients age 18 years or more; 2. Histologically confirmed diagnosis of non-small-cell lung carcinoma; 3. Only patients with advanced disease defined as stage IV or IIIB with or without pleural effusion will be included. In the event of IIIB disease without pleural effusion those patients, who for some reason (respiratory disease, large radiation volume...) may not be candidates to have chemotherapy and radiotherapy treatment and may only be treated with chemotherapy, will be considered; 4. Tumor specimen available (according to the criterion of the specimenprocessing laboratory) for the analysis of RAP80 and BRCA1 expression in mRNA; 5. A measurable lesion, as defined by RECIST criteria; 6. Karnofsky score 80% or more (ECOG =1.5*10^9/L, Hb >=10g/dl, Platelets >=100*10^9/L; 10. Patients with the following biochemical values: Bilirubin =60 ml/min; 11. Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study; 12. Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological specimens of tumor and blood; 13. Patients must be available for clinical follow-up.follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy treatment, except the supposition reflected in inclusion criterion 7; 2. Patients diagnosed of another neoplasm, with the exception of cervical carcinoma in situ, treated squamous cell carcinomas or superficial bladder tumors (Ta and TIS), or other malignant tumors that have received curative treatment within the last 5 years before inclusion in the study; 3. Patients with serious active bacterial or fungal infective processes from a clinical vantage point (= grade 2 of NCI-CTC, Version 3); 4. Patients who have received an investigational medicinal product in the 21 days before inclusion in the study; 5. Patients with HIV infection, HCV infection, coronary artery disease or uncontrolled arrhythmia, uncontrolled cerebrovascular disease, or other clinical conditions that, in the judgment of the investigator, contraindicate the patient's participation in the study; 6. Patients who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test performed within 7 days before the onset of treatment; 7. Substance abuse and clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance; 8. Patients who present any contraindication or suspected allergy to the products under investigation in the study; 9. Impossibility to comply with chemotherapy treatment due to cultural or geographic circumstances; 10. Significant weight loss (= 10% of body weight) in the 6 weeks before inclusion in the study; 11. Any condition that is unstable or could endanger the patient's safety and/or the patient's compliance with the study; 12. Contraindication for steroid use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;response rate;Safty; | — |
Countries
China
Contacts
Public ContactBAORUI LIU
Outcome results
None listed