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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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