Non-mall-Cell Lung Cancer
Conditions
Interventions
Trail Group:RRM1, TUBB3, ERCC1 Gene Detect
Control group:No Gene Detect
Sponsors
Department of Cardiothoracic Surgery, Southwest Hospital, Third Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have received surgical resection and histologically confirmed non-small-cell lung cancer which TNM stage was from Ib to IIIa (according to the 7th edition of the tumor node metastasis (TNM) classification system); 2. Patient must have need and be willing to receive adjuvant chemotherapy for 4 cycle after one mouth postoperation; 3. The EGFR, ALK, ROS1, RET, HER2, BRAF, MET gene mutation/change Status of patients is unknown or does not detected any therapeutic significance mutation/change; 4. The age of the Patients should be greater than 18 years; 5. Patients must have a Life Expectancy of greater than 6 mouths; 6. Patients must have an electrocorticography (ECOG) performance status 0 or 1 (Karnofsky > 70); 7. Patients must have normal organ and marrow function as defined below, within one week prior to randomizationabsolute neutrophil count>1,500/mLplatelets>100,000/mLTotal bilirubinwithin normal institutional limits, AST (SGOT)/ALT (SGPT)<2.5×institutional upper limit of normal, creatinine =1.5×institutional upper limit of normal; 8. Women who have child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this studyshe should inform her treating physician immediately; 9. Patients must have an international normalized ratio (INR)<1.5 and a partial thromboplastin time (PT) no greater than upper limits of normal within 1 week prior to randomization; 10. Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled intercurrent illness includingbut not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements; 2. Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 1 mouths prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible; 3. Patients receiving any other investigational agents; 4. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Gemcitabinepaclitaxel and platinum or other agents used in the study are excluded; 5. Pregnant or breastfeeding women are excluded from this study; 6. Patients who are HIV-positive on combination antiretroviral therapy due to the potential for lethal infections when treated with marrow-suppressive therapy; 7. Prior use of radiotherapychemotherapy or other anti-cancer and targeted therapy; 8. Prior or duration of the clinical trail, patient desire to receive other anti-cancer and targeted therapy; 9. Unacceptable Serious adverse effect occurred during the clinical trail; 10. The patients which RRM1, TUBB3, ERCC1 gene mRNA were highly expressed (>75%).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year Tumor Progression-free Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Three-year Tumor Progression-free Survival Rate;Three-years Overall Survival; | — |
Countries
China
Contacts
Public ContactHaidong Wang
Southwest Hospital, Third Military Medical University, Chongqing
Outcome results
None listed