Clinical trial NCT02943798: Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
Official title: Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pulmonary Large Cell Neuroendocrine Carcinoma
Keywords: Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: Tumor response
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Chest Hospital
name: Zhen Zhou, MD
role: STUDY_CHAIR
References:
citation: Fasano M, Della Corte CM, Papaccio F, Ciardiello F, Morgillo F. Pulmonary Large-Cell Neuroendocrine Carcinoma: From Epidemiology to Therapy. J Thorac Oncol. 2015 Aug;10(8):1133-41. doi: 10.1097/JTO.0000000000000589.