Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment quality-of-life assessment
Sponsor National Hospital Organization Kinki-chuo Chest Medical Center
Start date April 2004
Trial identifier NCT00242983, CDR0000450163, NHOK-BRI-LC03-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

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
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)"
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).