Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study

Conditions
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Pulmonary Large Cell Neuroendocrine Carcinoma

Intervention / Treatment
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* Drug: etoposide plus carboplatin
* Drug: Paclitaxel plus carboplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients will be administered with etoposide plus carboplatin as first-line treatment. | Drug: etoposide plus carboplatin<br>* 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.<br>* Other names: VP-16;|
| Experimental: Group B<br>Patients will be administered with paclitaxel plus carboplatin as first-line treatment. | Drug: Paclitaxel plus carboplatin<br>* 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.<br>* Other names: Taxol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Interval from randomization to disease progression, or untolerated toxicity | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Percentage of complete response and partial response | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy