Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-06-30

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

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Detailed Description

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

Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gemcitabine

gemcitabine 1000mg/m2，d1，d8，Q3W

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

gemcitabine 1000mg/m2，d1，d8，Q3W

observation group

observation

Group Type OTHER

observation group

Intervention Type OTHER

observation group

Interventions

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gemcitabine

gemcitabine 1000mg/m2，d1，d8，Q3W

Intervention Type DRUG

observation group

Intervention Type OTHER

Other Intervention Names

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gemcitabine 1000mg/m2，d1，d8，Q3W

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No