Clinical Trial: Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 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.

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.


Sponsor: Shanghai Chest Hospital

Current Primary Outcome: Progression-free survival [ Time Frame: 6 months ]

Interval from randomization to disease progression, or untolerated toxicity


Original Primary Outcome: Same as current

Current Secondary Outcome: Tumor response [ Time Frame: 2 months ]

Percentage of complete response and partial response


Original Secondary Outcome: Same as current

Information By: Shanghai Chest Hospital

Dates:
Date Received: October 22, 2016
Date Started: December 2016
Date Completion: December 2018
Last Updated: October 22, 2016
Last Verified: October 2016