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OpenTrials
Completed

NCT Number: NCT01797913

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8

Primary outcomes

  1. PFS

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2008
Primary completion
2015
First posted
Feb 25, 2013
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.