Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00022009|
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 12, 2003
Last Update Posted : September 20, 2013
|First Submitted Date ICMJE||August 10, 2001|
|First Posted Date ICMJE||June 12, 2003|
|Last Update Posted Date||September 20, 2013|
|Study Start Date ICMJE||July 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00022009 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer|
|Official Title ICMJE||Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Treatment plus supportive care may improve quality of life in patients undergoing cancer treatment.
PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients on both arms also receive best supportive care. Additional courses of gemcitabine may be administered at the discretion of the investigator.
Quality of life is assessed at baseline and then after each course of chemotherapy.
Patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 174 patients (87 per treatment arm) will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Lung Cancer|
|Intervention ICMJE||Drug: gemcitabine hydrochloride|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00022009|
|Other Study ID Numbers ICMJE||CDR0000068683
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The Christie NHS Foundation Trust|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||October 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP