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)"
18 Years
N/A
Both
Lung Cancer
Trial Information
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)"
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
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
Principal Investigator
Masaaki Kawahara, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Hospital Organization - Osaka National Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000450163
NCT ID:
NCT00242983
Start Date:
April 2004
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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