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Quality of Life in Patients Who Are Receiving Either Vinorelbine, Gemcitabine, and Docetaxel or Paclitaxel and Carboplatin for Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment
Lung Cancer Procedure: quality-of-life assessment

Detailed Description:


  • 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.

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Study Type : Observational
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)"
Study Start Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified



  • See Disease Characteristics


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242983

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Toyohashi Municipal Hospital
Aichi, Japan, 466-8560
Ichinomiyanishi Hospital
Aichi, Japan, 491-0201
Asahikawa Medical College
Asahikawa, Japan, 078 8510
National Cancer Center Hospital East
Chiba-ken, Japan, 277-8577
Shikoku Cancer Center Hospital
Ehime, Japan, 790-0007
National Hospital Organization - Nishigunma National Hospital
Gumna, Japan, 377-8511
Gunma Cancer Center
Gunma, Japan, 373-8550
National Hospital Organization - Dohoku National Hospital
Hokkaido, Japan, 070-0901
Junshinkai Tsuna Hospital
Hyogo, Japan, 663-8501
Takarazuka Municipal Hospital
Hyogo, Japan, 665-0827
Fujisawa City Hospital
Kanagawa, Japan, 251-8550
National Hospital Organization - Minamikyoto Medical Center
Kyoto, Japan, 610-0113
Miyagi Cancer Center
Miyagi, Japan, 981-1293
National Hospital Organization - Okayama Medical Center
Okayama, Japan, 701-1192
Osaka General Medical Center
Osaka-shi, Japan, 558-0056
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
National Hospital Organization - Osaka National Hospital
Osaka, Japan, 591-8555
Saitama Cardiovascular and Respiratory Center
Saitama, Japan, 360-0105
Tokyo Medical University
Tokyo, Japan, 160
Tottori University Hospital
Tottori, Japan, 683-8504
Koseiren Takaoka Hospital
Toyama, Japan, 933-8555
Sponsors and Collaborators
National Hospital Organization Kinki-chuo Chest Medical Center
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Study Chair: Masaaki Kawahara, MD National Hospital Organization - Osaka National Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00242983     History of Changes
Other Study ID Numbers: CDR0000450163
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2005

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
large cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs