Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and safety of nab-paclitaxel with topotecan as second-line treatment for patients with extensive stage small cell lung cancer.

Official Title
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The Efficacy and Safety of Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer: A Multicenter, Randomized Controlled Study

Conditions
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Extensive Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: nab-paclitaxel
* Drug: Topotecan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.18 to 75years, male or female; 2.Histological or pathological diagnosis of small cell lung caner; 3.Progression or relapse after first-line chemotherapy, extensive disease; 4.ECOG performance status of 0-2; 5.Life expectancy of 3 months or more; 6.Patient must be accessible for treatment and follow-up; 7.For women of child-bearing age, the pregnancy test results (serum or urine) within 72 hours before enrolment must be negative. They will take appropriate methods for contraception during the study; 8.Signed informed consent. Exclusion Criteria: symptomatic brain metastases; Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; Have dementia, altered mental state or any mental illness that would prevent understanding or informed consent or fill out questionnaires; Received any investigational drug within 30 days of the planned first dose of this study treatment. Prior Grade ≥ 2 peripheral neuropathy(according to (NCI CTCAE), version 5.0); Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients; Have malignant tumors in the past 5 years, except for clinically cured basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and ductal carcinoma in situ after radical operation; Bone marrow function: Neutrophils < 1.5×109/L, platelets < 100×109/L, hemoglobin < 90 g/L; Hepatic and renal function: Serum creatinine > 1.5×ULN; AST and ALT > 2.5×ULN or > 5×ULN in the presence of hepatic metastasis; Total bilirubin >1.5×ULN; Patients need other anti-tumor drugs; Known HIV, hepatitis B/C virus positive ; The researchers considered the patients who were not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nab-paclitaxel<br>nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles | Drug: nab-paclitaxel<br>* Drug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles.<br>|
| Active Comparator: Topotecan<br>Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles. | Drug: Topotecan<br>* Drug: Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS was defined as the time from the date of the first administration of trial regimen to the date of death from any cause (event) or last follow-up (censored data). | 1 years post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Response evaluation disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) criteria. Response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases. | 1 years | 
| Progression free survival (PFS) | The time from treatment to tumor progression or death | 1 years | 
| Adverse events (AE) | Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nab-paclitaxel Topotecan