Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
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|ClinicalTrials.gov Identifier: NCT02943798|
Recruitment Status : Unknown
Verified October 2016 by Zhou Zhen, Shanghai Chest Hospital.
Recruitment status was: Not yet recruiting
First Posted : October 25, 2016
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Large Cell Neuroendocrine Carcinoma||Drug: etoposide plus carboplatin Drug: Paclitaxel plus carboplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Group A
Patients will be administered with etoposide plus carboplatin as first-line treatment.
Drug: etoposide 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.
Other Name: VP-16
Experimental: Group B
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
Drug: Paclitaxel plus carboplatin
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.
Other Name: Taxol
- Progression-free survival [ Time Frame: 6 months ]Interval from randomization to disease progression, or untolerated toxicity
- Tumor response [ Time Frame: 2 months ]Percentage of complete response and partial response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943798
|Contact: Zhen Zhou, MDfirstname.lastname@example.org|
|Study Chair:||Zhen Zhou, MD||Shanghai Chest Hospital|