Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

Phase 2

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: gemcitabine; Other: observation group

• Registration Number: NCT02039518
• Lead Sponsor: Fudan University

Brief 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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-30
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-15
• Last Update Submitted: 2014-01-15
• Study First Posted: 2014-01-17
• Last Update Posted: 2014-01-17
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemcitabine	gemcitabine	gemcitabine 1000mg/m2，d1，d8，Q3W
observation group	observation group	observation

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	from the first cycle of treatment (day one) to two month after the last cycle

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China