Back to resultsOptimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
Primary Purpose
Pulmonary Large Cell Neuroendocrine Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
etoposide plus carboplatin
Paclitaxel plus carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Large Cell Neuroendocrine Carcinoma focused on measuring Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Patients will be administered with etoposide plus carboplatin as first-line treatment.
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
Outcomes
Primary Outcome Measures
Progression-free survival
Interval from randomization to disease progression, or untolerated toxicity
Secondary Outcome Measures
Tumor response
Percentage of complete response and partial response
Full Information
NCT ID
NCT02943798
First Posted
October 22, 2016
Last Updated
October 22, 2016
Sponsor
Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02943798
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Large Cell Neuroendocrine Carcinoma
Keywords
Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients will be administered with etoposide plus carboplatin as first-line treatment.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients will be administered with paclitaxel plus carboplatin as first-line treatment.
Intervention Type
Drug
Intervention Name(s)
etoposide plus carboplatin
Other Intervention Name(s)
VP-16
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel plus carboplatin
Other Intervention Name(s)
Taxol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Interval from randomization to disease progression, or untolerated toxicity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tumor response
Description
Percentage of complete response and partial response
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Zhou, MD
Email
jenniferzhou1116@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Zhou, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26039012
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.
Results Reference
result
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Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
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