- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242983
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)"
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Contacts and Locations
Study Locations
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-
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Aichi, Japan, 466-8560
- Toyohashi Municipal Hospital
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Aichi, Japan, 491-0201
- Ichinomiyanishi Hospital
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Asahikawa, Japan, 078 8510
- Asahikawa Medical College
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Chiba-ken, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime, Japan, 790-0007
- Shikoku Cancer Center Hospital
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Gumna, Japan, 377-8511
- National Hospital Organization - Nishigunma National Hospital
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Gunma, Japan, 373-8550
- Gunma Cancer Center
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Hokkaido, Japan, 070-0901
- National Hospital Organization - Dohoku National Hospital
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Hyogo, Japan, 663-8501
- Junshinkai Tsuna Hospital
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Hyogo, Japan, 665-0827
- Takarazuka Municipal Hospital
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Kanagawa, Japan, 251-8550
- Fujisawa City Hospital
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Kyoto, Japan, 610-0113
- National Hospital Organization - Minamikyoto Medical Center
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Miyagi, Japan, 981-1293
- Miyagi Cancer Center
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Okayama, Japan, 701-1192
- National Hospital Organization - Okayama Medical Center
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Osaka, Japan, 553-0003
- Osaka Kosei Nenkin Hospital
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Osaka, Japan, 591-8555
- National Hospital Organization - Osaka National Hospital
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Osaka-shi, Japan, 558-0056
- Osaka General Medical Center
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Saitama, Japan, 360-0105
- Saitama Cardiovascular and Respiratory Center
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Tokyo, Japan, 160
- Tokyo Medical University
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Tottori, Japan, 683-8504
- Tottori University Hospital
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Toyama, Japan, 933-8555
- Koseiren Takaoka Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
What is the study measuring?
Primary Outcome Measures
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
|
Secondary Outcome Measures
Outcome Measure |
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Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal
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Collaborators and Investigators
Investigators
- Study Chair: Masaaki Kawahara, MD, National Hospital Organization Osaka National Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000450163
- NHOK-BRI-LC03-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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