Pulmonary Large Cell Neuroendocrine CarcinomaPhase 2NCT02943798
Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma
A Phase 2 study testing etoposide plus carboplatin and Paclitaxel plus carboplatin in people with Pulmonary Large Cell Neuroendocrine Carcinoma, run by Shanghai Chest Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Large Cell Neuroendocrine Carcinoma
- What is being tested?
- etoposide plus carboplatin and Paclitaxel plus carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Zhen Zhou, MD contact
About this study
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.
Read the 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.
- Being tested
- etoposide plus carboplatin, Paclitaxel plus carboplatin
- Keywords
- Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoposide plus carboplatinDrug
Also called VP-16
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 carboplatinDrug
Also called Taxol
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be administered with etoposide plus carboplatin as first-line treatment. Receives: Drug: etoposide plus carboplatin |
| Group B | Experimental | Patients will be administered with paclitaxel plus carboplatin as first-line treatment. Receives: Drug: Paclitaxel plus carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Interval from randomization to disease progression, or untolerated toxicity
Measured: 6 months
Secondary outcomes (1)
Tumor response
Percentage of complete response and partial response
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Large Cell Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Zhen, Shanghai Chest Hospital
- Investigators
- Zhen Zhou, MD, Study chair, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943798
- Sponsor's protocol ID
- Chest003
- Status last verified
- Oct 2016
- First submitted
- 22 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26039012
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization for the Treatment of Advanced Pulmonary Large Cell Neuroendocrine Carcinoma: a Prospective, Randomized, Open-label, Phase 2 Study
- ClinicalTrials.gov ID
- NCT02943798
- Acronym / sponsor ID
- Chest003
- Keywords
- Pulmonary Large Cell Neuroendocrine Carcinoma,chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: etoposide plus carboplatinPatients will be administered with etoposide plus carboplatin as first-line treatment. |
| Group B | Experimental | Drug: Paclitaxel plus carboplatinPatients will be administered with paclitaxel plus carboplatin as first-line treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etoposide plus carboplatinAlso: VP-16etoposide 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. | Drug | Group A |
| Paclitaxel plus carboplatinAlso: TaxolPaclitaxel 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. | Drug | Group B |
Primary outcome
Progression-free survival
Time frame: 6 months
Interval from randomization to disease progression, or untolerated toxicity
1 secondary outcome
Tumor response
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Results publication: PubMed 26039012Fasano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Zhou, MD contact
Zhen Zhou, MD study chair
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etoposide plus carboplatin and Paclitaxel plus carboplatin in people with Pulmonary Large Cell Neuroendocrine Carcinoma, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhen Zhou, MD (jenniferzhou1116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.