Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02039518
• Other study ID #: WXH-gemcitabine-SCLC
• Status: Recruiting
• Phase: Phase 2
• First received: December 30, 2013
• Last updated: January 15, 2014
• Start date: December 2013
• Est. completion date: June 2017

Study information

• Verified date: January 2014
• Source: Fudan University
• Contact: Wu X Hua, doctor
• Phone: 13482888167
• Email: xhwu2011[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• gemcitabine
gemcitabine 1000mg/m2,d1,d8,Q3W

Other:
• observation group
observation group

Locations

Country	Name	City	State
China	Cancer hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		from the first cycle of treatment (day one) to two month after the last cycle	No