Pulmonary Large Cell Neuroendocrine Carcinoma Clinical Trial
Official title:
Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study
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.
| Status | Not yet recruiting |
| Enrollment | 118 |
| Est. completion date | December 2018 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Chest Hospital |
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival | Interval from randomization to disease progression, or untolerated toxicity | 6 months | No |
| Secondary | Tumor response | Percentage of complete response and partial response | 2 months | No |