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Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

Primary Purpose

Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gemcitabine
observation group
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Progression free Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cancer hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

gemcitabine

observation group

Arm Description

gemcitabine 1000mg/m2,d1,d8,Q3W

observation

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Full Information

First Posted
December 30, 2013
Last Updated
January 15, 2014
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02039518
Brief Title
Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients
Official Title
Randomized Controlled Trial of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Progression free Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine
Arm Type
Experimental
Arm Description
gemcitabine 1000mg/m2,d1,d8,Q3W
Arm Title
observation group
Arm Type
Other
Arm Description
observation
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
gemcitabine 1000mg/m2,d1,d8,Q3W
Intervention Description
gemcitabine 1000mg/m2,d1,d8,Q3W
Intervention Type
Other
Intervention Name(s)
observation group
Intervention Description
observation group
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu X Hua, doctor
Phone
13482888167
Email
xhwu2011@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WU X HUA, DOCTOR
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu X hua, doctor
Phone
13482888167
Email
xhwu2011@yahoo.com

12. IPD Sharing Statement

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Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

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