Large cell neuroendocrine carcinoma
Conditions
Interventions
EC:Etoposide and Carboplatin
TC:Paclitaxel and Carboplatin
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1,Patients has the ability to understand and provide signed informed consent. 2,Patient is between 18 and 75 years of age at the time of informed consent. 3,Patient has the ability to comply with study procedures. 4,Patient has diagnosed locally advanced or replased (stage IV)or metastatic pulmonary large cell neuroendocrine carcinoma confirmed by histology or cytology (stage IIIB, and is not a candidate for multimodality therapy). Diagnose by Sputum cytology is not accepted. 5,Patient has a WHO performance status (ECOG PS)0-1 6,Patient has life expectancy =12 weeks. 7,Patient must meet the following laboratory values: ANC=1.5 x 109/L; Plateles=100 x 109/L; Hemoglobin(Hgb) =9 g/dL(Blood transfusion can used to maintain or over the laboratory) 8,Patients must meet the following laboratory values: Total bilirubin<1.5*ULN, Aspartate transaminase(AST) and Alanine transaminase (ALP) <2.5 x ULN, except for patients without liver metastasis. ALT and AST <5 x ULN, except for patient with liver metastasis. 9,Patients must meet the following laboratory values: Serum creatinine=1.5x ULN and/or calculated creatinine clearance =50mL/min 10,International normalization ratio(INR) =1.5, PTT or aPTT= 1.5 x ULN
Exclusion criteria
Exclusion criteria: 1,Patient with other pathologic type and stages 2,Patient has history of chemotherapy or targeted therapy. 3,Patient is receiving other anti-tumor therapy. 4,Patients who has received thoracic radiotherapy to lung fields =28 days prior to starting the study treatment. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy =2 weeks. 5,Patients has had major surgery(including VATS biopsy) within 28 days prior to starting study treatment, or big trauma, or patients plan to receive major surgery during study progress. 6,Patients without measurable lesion 7,Patients has other severe, acute, or chronic medical conditions including : the central nervous system metastases not control; (clinical manifestations of stable without treatment or asymptomatic patients with brain metastases can be enrolled); Unable control the hypertension, myocardial infarction, unstable angina or appeared symptoms of congestive heart failure in the past 12 months or arrhythmia, beyond the control of the active hemorrhagic mucosal diseases such as gastrointestinal bleeding; the peripheral neuropathy at degree III,; Bacteria, fungi or viruses infection disease activity; Pregnancy or lactation women; During the study period and during the last six months after the administration, complete with uterus (except postmenopausal status in the past 24 months), but not using effective contraception. Has a history of mental illness is not easy to controlUncrontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results. 8,Patients cant stop using Non steroidal anti-inflammatory drugs. 9,Patients with history of active malignant tumor, except for melanoma tumor, cervical carcinoma in situ, treated prostatic cancer. 10,Patients with allergic constitution. 11,Patient with non- complance 12,Patient need anti-tumor therapy for pleural effusion, or peritoneal effusion, or pericardial effusion 13,Patient participate in other clinical trail within 1 month prior to random. 14,In the opinion of investigator, patient may not fit this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective release rate; | — |
Countries
China
Contacts
Public ContactZHOU ZHEN
Shanghai Chest Hospital
Outcome results
None listed