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

  • China
    • 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:

  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 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
Drug: gemcitabine
gemcitabine 1000mg/m2，d1，d8，Q3W
Other Names:
  • gemcitabine 1000mg/m2，d1，d8，Q3W
Other: observation group
observation
Other: observation group
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

Fudan University

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

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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