Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer
NCT ID: NCT00242983
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
OBSERVATIONAL
2004-04-30
Brief Summary
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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.
Detailed Description
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* Compare the quality of life of patients with advanced non-small cell lung cancer treated with vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin on protocol JMTO-LC00-03.
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.
Conditions
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Keywords
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Interventions
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quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:
* Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
* Newly diagnosed stage IV disease
* Recurrent disease after prior surgery and/or radiotherapy
* Any of the following cellular subtypes are allowed:
* Adenocarcinoma
* Large cell carcinoma
* Squamous cell carcinoma
* Unspecified carcinoma
* Enrolled on protocol JMTO-LC00-03
PATIENT CHARACTERISTICS:
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
PRIOR CONCURRENT THERAPY:
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Hospital Organization Kinki-chuo Chest Medical Center
OTHER
Principal Investigators
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Masaaki Kawahara, MD
Role: STUDY_CHAIR
National Hospital Organization Osaka National Hospital
Locations
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Toyohashi Municipal Hospital
Aichi, , Japan
Ichinomiyanishi Hospital
Aichi, , Japan
Asahikawa Medical College
Asahikawa, , Japan
National Cancer Center Hospital East
Chiba-ken, , Japan
Shikoku Cancer Center Hospital
Ehime, , Japan
National Hospital Organization - Nishigunma National Hospital
Gumna, , Japan
Gunma Cancer Center
Gunma, , Japan
National Hospital Organization - Dohoku National Hospital
Hokkaido, , Japan
Junshinkai Tsuna Hospital
Hyōgo, , Japan
Takarazuka Municipal Hospital
Hyōgo, , Japan
Fujisawa City Hospital
Kanagawa, , Japan
National Hospital Organization - Minamikyoto Medical Center
Kyoto, , Japan
Miyagi Cancer Center
Miyagi, , Japan
National Hospital Organization - Okayama Medical Center
Okayama, , Japan
Osaka Kosei Nenkin Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
National Hospital Organization - Osaka National Hospital
Osaka, , Japan
Saitama Cardiovascular and Respiratory Center
Saitama, , Japan
Tokyo Medical University
Tokyo, , Japan
Tottori University Hospital
Tottori, , Japan
Koseiren Takaoka Hospital
Toyama, , Japan
Countries
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References
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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.
Other Identifiers
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NHOK-BRI-LC03-01
Identifier Type: -
Identifier Source: secondary_id
CDR0000450163
Identifier Type: -
Identifier Source: org_study_id