Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02039518

Enrollment

160

Registered

2014-01-17

Start date

2013-12-31

Completion date

2017-06-30

Last updated

2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

Progression free Survival

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

Interventions

DRUGgemcitabine

gemcitabine 1000mg/m2，d1，d8，Q3W

OTHERobservation group

observation group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactWu X Hua, doctor

xhwu2011@yahoo.com13482888167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026