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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

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00242983
Enrollment
Unknown
Registered
2005-10-21
Start date
2004-04-30
Completion date
Unknown
Last updated
2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

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.

Interventions

PROCEDUREquality-of-life assessment

Sponsors

National Hospital Organization Kinki-chuo Chest Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026