Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Other: observation group; Drug: gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02039518

WXH-gemcitabine-SCLC

Details and patient eligibility

About

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

Full description

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

gemcitabine

Experimental group

Description:

gemcitabine 1000mg/m2，d1，d8，Q3W

Treatment:

Drug: gemcitabine

observation group

Other group

Description:

observation

Treatment:

Other: observation group