NCT01797913

Brief Summary

assess the efficacy and safety of gemcitabine in the maintenance treatment of advanced non-small cell lung cancer

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

6.5 years

First QC Date

February 21, 2013

Last Update Submit

February 22, 2016

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • PFS

    from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (1)

gemcitabine

EXPERIMENTAL
Drug: gemcitabine

Interventions

gemcitabineDRUG

gemcitabine，1000mg/m2，ivgtt，DAY1\&DAY8

gemcitabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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.
  • \~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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director of department of chemotherapy

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

August 1, 2008

Primary Completion

February 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

CN(1)