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| Sponsor: | National Hospital Organization Kinki-chuo Chest Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00242983 |
Purpose
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 |
|---|---|
|
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000450163, NHOK-BRI-LC03-01 |
| Study First Received: | October 20, 2005 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00242983 History of Changes |
| 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 Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Vinorelbine Radiation-Sensitizing Agents Lung Diseases Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
