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

• Conditions: Lung Cancer

• Registration Number: NCT00242983
• Lead Sponsor: National Hospital Organization Kinki-chuo Chest Medical Center

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.

Detailed Description

OBJECTIVES:

* 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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-10-20
• Study First Submitted QC: 2005-10-20
• Study First Posted: 2005-10-21
• Status Verified: 2005-12
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

Trial Locations

Locations (21)

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; 🇯🇵 Hyogo, Japan

Takarazuka Municipal Hospital; 🇯🇵 Hyogo, Japan

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