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Sponsored by: |
National Hospital Organization Kinki-chuo Chest Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00242983 |
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.
Condition | Intervention |
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Lung Cancer |
Procedure: quality-of-life assessment |
Study Type: | Observational |
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)" |
Study Start Date: | April 2004 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:
Any of the following cellular subtypes are allowed:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Radiotherapy
Surgery
Japan | |
Asahikawa Medical College | |
Asahikawa, Japan, 078 8510 | |
Fujisawa City Hospital | |
Kanagawa, Japan, 251-8550 | |
Gunma Cancer Center | |
Gunma, Japan, 373-8550 | |
Ichinomiyanishi Hospital | |
Aichi, Japan, 491-0201 | |
Junshinkai Tsuna Hospital | |
Hyogo, Japan, 663-8501 | |
Koseiren Takaoka Hospital | |
Toyama, Japan, 933-8555 | |
Miyagi Cancer Center | |
Miyagi, Japan, 981-1293 | |
National Cancer Center Hospital East | |
Chiba-ken, Japan, 277-8577 | |
National Hospital Organization - Dohoku National Hospital | |
Hokkaido, Japan, 070-0901 | |
National Hospital Organization - Minamikyoto Medical Center | |
Kyoto, Japan, 610-0113 | |
Toyohashi Municipal Hospital | |
Aichi, Japan, 466-8560 | |
National Hospital Organization - Okayama Medical Center | |
Okayama, Japan, 701-1192 | |
National Hospital Organization - Osaka National Hospital | |
Osaka, Japan, 591-8555 | |
Osaka General Medical Center | |
Osaka-shi, Japan, 558-0056 | |
Osaka Kosei Nenkin Hospital | |
Osaka, Japan, 553-0003 | |
Saitama Cardiovascular and Respiratory Center | |
Saitama, Japan, 360-0105 | |
Shikoku Cancer Center Hospital | |
Ehime, Japan, 790-0007 | |
Takarazuka Municipal Hospital | |
Hyogo, Japan, 665-0827 | |
Tokyo Medical University | |
Tokyo, Japan, 160 | |
Tottori University Hospital | |
Tottori, Japan, 683-8504 | |
National Hospital Organization - Nishigunma National Hospital | |
Gumna, Japan, 377-8511 |
Study Chair: | Masaaki Kawahara, MD | National Hospital Organization - Osaka National Hospital |
Study ID Numbers: | CDR0000450163, NHOK-BRI-LC03-01 |
Study First Received: | October 20, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00242983 |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Non-small cell lung cancer Quality of Life Carboplatin Recurrence Carcinoma Docetaxel Vinorelbine Adenocarcinoma of lung |
Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Adenocarcinoma Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Pharmacologic Actions |