Pulmonary Large Cell Neuroendocrine Carcinoma
Conditions
Keywords
Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
Brief summary
The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma.
Detailed description
The primary endpoint is to compare the PFS (progress-free survival ) of etoposide plus carboplatin with paclitaxel combined with carboplatin as first-line treatment for advanced pulmonary large cell neuroendocrine carcinoma. In addition, gene spectrum detection and Mini-PDX are applied for validation of pharmacodynamic. Results of clinical trials and pharmacodynamic test will be analyzed to provide evidence for the precise treatment for LCNEC.
Interventions
DRUGetoposide plus carboplatin
etoposide is administered by venus with a dose of 100mg/m2 from day 1 to3, and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
Paclitaxel is administered by venus with a dose of 175 mg/m2 from day 1 and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Stage IIIB or IV pulmonary large-cell neuroendocrine carcinoma confirmed by histology or cytology * Estimated life expectancy over 3 months * Performance status 0,1,2 * Signed informed consent * Adequate organ functions: absolute neutrophil count (ANC) over 1,500 cells/mm3 (1.5 x 109/L); platelet count over100,000/mm3 (100 x 109/L); serum creatinine \< 2.5 mg/dL (221 mmol/L); serum AST or ALT \<5.0 x upper limit of normal (ULN); serum total bilirubin \<2.0 mg/dL (34 mmol/L)
Exclusion criteria
* History of chemotherapy or molecular targeted therapy * Thoracic radical radiotherapy within 28 days of the initiation of study drug therapy except for palliative radiotherapy * Use of any standard/experimental anti-cancer drug therapy within 28 days of the initiation of study drug therapy * Prior history of malignancies other than non-small cell lung cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for \> or = to 1 year * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Pregnant or lactating * Patient with concurrent medical or psychiatric illness which would, in the opinion of the investigator, prevent compliance with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 6 months | Interval from randomization to disease progression, or untolerated toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 2 months | Percentage of complete response and partial response |
Contacts
Primary ContactZhen Zhou, MD
Outcome results
None listed