The Study of Gemcitabine in the Maintenance Treatment of... | NCT01797913

Studies
The Study of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

NCT01797913

Sponsor

Fudan University

Status

Completed

Last Update Posted

Feb 23, 2016Estimated

Enrollment

70Actual

Phase

Phase 2

Conditions

THE Efficacy and Safety of Gemcitabine in the Maintenance Treatment of Advanced Non-small Cell Lung Cancer

Interventions

gemcitabine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Feb 2015Actual

Completion Date

Not provided

First Submitted Date

Feb 21, 2013

First Submission Date that Met QC Criteria

Feb 21, 2013

First Posted Date

Feb 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2016

Last Update Posted Date

Feb 23, 2016Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Label	Type	Description	Intervention Names
gemcitabine	Experimental		Drug: gemcitabine

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine	Drug	gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8	gemcitabine

Measure	Description	Time Frame
PFS		from the first cycle of treatment (day one) to two month after the last cycle

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18~75 years Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer patients who have acceptted combination chemotherapy based on platinum 4 course,SD OR PR,the CR patients should accept 6 course of combination chemotherapy.

3~8 weeks after patients complete first line chemotherapy(include radiotherapy) Ecog0-2 Expected life time longer than 3 monthes

Normal laboratory values:

leucocyte ≥ 4×109/L
neutrophil ≥ 1.5×109/L
platelet ≥ 100×109/L
Hemoglobin ≥ 10g/L
ALT and
AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) Signed written informed consent

Exclusion Criteria:

Patients have used drugs according to protocol
Uncontrolled infection of Bacterial or virus or fungal
Patients with other malignant tumor
Uncontrolled brain metastases
Female patients during their pregnant and lactation period, or patients without contracep

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cancer hospital Fudan University		Shanghai	Shanghai Municipality	200032	China

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided