Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients
Conditions
Small Cell Lung Cancer
Conditions: official terms
Small Cell Lung Carcinoma
Conditions: Keywords
Progression free Survival
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: gemcitabine Type: Drug
Name: observation group Type: Other
Overall Status
Recruiting
Summary
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
from the first cycle of treatment (day one) to two month after the last cycle
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. ≥18 years

2. PS=0,1,2

3. Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer

4. Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD

5. Expected lifetime>12 weeks

6. 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:

1. Tbil> 1.5×ULN

2. ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)

3. Severe symptomatic heart disease

4. Symptomatic brain metastases

5. In the last 5 years have been or are suffering from other histological types of malignant tumor

6. There are serious or uncontrolled systemic diseases

7. During the study period planned radiotherapy on target lesion

8. During the study period, plans to use other antineoplastic therapy

9. Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Location
Cancer hospital Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: Wu X hua, doctor - 13482888167 - xhwu2011@yahoo.com
Start Date
December 2013
Completion Date
June 2017
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page