Lung Adenocarcinoma
Conditions
Keywords
erlotinib, pemetrexed, maintenance therapy
Brief summary
The purpose of this study is to compare effects of erlotinib and pemetrexed as maintenance therapy for lung adenocarcinoma. Primary Outcome is the progression free survival (PFS). Based on prediction of different potential benefit groups, this study may help the oncologist to optimize and improve the maintenance therapy plan for lung adenocarcinoma.
Interventions
DRUGErlotinib, Pemetrexed
followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically diagnosed stage III/IV Lung Adenocarcinoma; * Age of 18-75years; Gender Not Required; * Received systemic clinical examination, including chest X-ray, abdomen B ultrasound, head CT scan, radionuclide bone scan; * Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is SD or above SD (efficacy evaluation time is 21 days, if it is SD, then the longest diameter of target lesions shall not increase); * Adequate hematologic, renal, and hepatic function, Specific index as follows: liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\^9/l, ANC≥2.0×10\^9/l platelet count ≥100×10\^9/l, Hb≥100 g/l; * ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy; * The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI); * No history of serious drug allergy; * Informed consent should be obtained before treatment.
Exclusion criteria
* Not histologically or cytologically diagnosed as Lung Adenocarcinoma * The age of \>75 years or \<18 years. * Major organ dysfunction and Serious Heart Disease (congestive heart-failure, incontrollable high-risk arrhythmia, unstable angina, alular disease, myocardial infarct and Resistant hypertension,); * Serious complications and investigator consider it is unsuited enrolling; * Pregnant or lactating women; * Allergic to research drug; * Received cisplatin chemotherapy for 4 cycles before this study, the curative effect of chemotherapy is PD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | two years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | two years |
| Clinical benefit rate (CBR) | two years |
| Objective response rate (ORR) | two years |
| The adverse reaction | two years |
| Time to progression (TTP) | two years |
Contacts
Primary ContactJIANHUA CHEN, MD
Outcome results
None listed