- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02039518
Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients
January 15, 2014 updated by: Xianghua Wu, Fudan University
Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
from the first cycle of treatment (day one) to two month after the last cycle
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Cancer hospital Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ≥18 years
- PS=0,1,2
- Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer
- Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD
- Expected lifetime>12 weeks
- 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:
- Tbil> 1.5×ULN
- ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
- Severe symptomatic heart disease
- Symptomatic brain metastases
- In the last 5 years have been or are suffering from other histological types of malignant tumor
- There are serious or uncontrolled systemic diseases
- During the study period planned radiotherapy on target lesion
- During the study period, plans to use other antineoplastic therapy
- Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: gemcitabine
gemcitabine 1000mg/m2,d1,d8,Q3W
|
gemcitabine 1000mg/m2,d1,d8,Q3W
Other Names:
|
Other: observation group
observation
|
observation group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS)
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
|
from the first cycle of treatment (day one) to two month after the last cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: WU X HUA, DOCTOR, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
December 30, 2013
First Submitted That Met QC Criteria
January 15, 2014
First Posted (Estimate)
January 17, 2014
Study Record Updates
Last Update Posted (Estimate)
January 17, 2014
Last Update Submitted That Met QC Criteria
January 15, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- WXH-gemcitabine-SCLC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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