Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
NCT ID: NCT02943798
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
118 participants
INTERVENTIONAL
2016-12-31
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Patients will be administered with etoposide plus carboplatin as first-line treatment.
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.
Group B
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Chest Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhou Zhen
Chief Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhen Zhou, MD
Role: STUDY_CHAIR
Shanghai Chest Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Chest003
Identifier Type: -
Identifier Source: org_study_id