Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00242983|
Recruitment Status : Unknown
Verified December 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 21, 2005
Last Update Posted : December 18, 2013
|First Submitted Date||October 20, 2005|
|First Posted Date||October 21, 2005|
|Last Update Posted Date||December 18, 2013|
|Start Date||April 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Change in the total score from baseline measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at 9, 18, and 22 weeks or withdrawal|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00242983 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer|
|Official Title||Assessment of Quality of Life (QOL) in Patients Registered With "Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer (JMTO LC00-03)"|
RATIONALE: Studying quality-of-life in patients undergoing cancer treatment may help identify the intermediate and long-term effects of treatment on patients with cancer.
PURPOSE: This clinical trial is studying quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer.
OUTLINE: This is a multicenter study. Patients receive treatment on protocol JMTO-LC00-03.
Quality of life is assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L), FACT-Taxane, and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp) questionnaires at baseline, weeks 9 and 18, and at the completion of treatment.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention||Procedure: quality-of-life assessment|
|Study Groups/Cohorts||Not Provided|
|Publications *||Kawahara M, Tada H, Tokoro A, Teramukai S, Origasa H, Kubota K, Shinkai T, Fukushima M, Furuse K. Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01). BMC Cancer. 2011 Aug 17;11:356. doi: 10.1186/1471-2407-11-356.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Japan|
|Removed Location Countries|
|Other Study ID Numbers||CDR0000450163
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Hospital Organization Kinki-chuo Chest Medical Center|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||December 2005|