Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

Study Overview
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Brief Summary
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The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy

Detailed Description
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from the first cycle of treatment (day one) to two month after the last cycle

Official Title
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Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Other: observation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years PS=0,1,2 Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD Expected lifetime>12 weeks Signed written informed consent Exclusion Criteria: Small cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of >CTCAE caused tumor treatment past grade 2 toxicity Ccr<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency： Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN) Severe symptomatic heart disease Symptomatic brain metastases In the last 5 years have been or are suffering from other histological types of malignant tumor There are serious or uncontrolled systemic diseases During the study period planned radiotherapy on target lesion During the study period, plans to use other antineoplastic therapy Clinical study on treatment of 30 days beginning period prior to participate in any study drug

Ages Eligible for Study
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Minimum Age: 18 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: gemcitabine<br>gemcitabine 1000mg/m2，d1，d8，Q3W | Drug: gemcitabine<br>* gemcitabine 1000mg/m2，d1，d8，Q3W<br>* Other names: gemcitabine 1000mg/m2，d1，d8，Q3W;|
| Other: observation group<br>observation | Other: observation group<br>* observation group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | from the first cycle of treatment (day one) to two month after the last cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progression free Survival