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| ID | Type | Description | Link |
|---|---|---|---|
| NHOK-BRI-LC03-01 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality-of-life assessment | Procedure |
| Measure | Description | Time 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the subscale from baseline of these questionnaires at 9, 18, and 22 weeks or withdrawal |
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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:
Enrolled on protocol JMTO-LC00-03
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Masaaki Kawahara, MD | National Hospital Organization Osaka National Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyohashi Municipal Hospital | Aichi | 466-8560 | Japan | |||
| Ichinomiyanishi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21849041 | Derived | Kawahara M, Tada H, Tokoro A, Teramukai S, Origasa H, Kubota K, Shinkai T, Fukushima M, Furuse K. Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01). BMC Cancer. 2011 Aug 17;11:356. doi: 10.1186/1471-2407-11-356. |
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| Aichi |
| 491-0201 |
| Japan |
| Asahikawa Medical College | Asahikawa | 078 8510 | Japan |
| National Cancer Center Hospital East | Chiba-ken | 277-8577 | Japan |
| Shikoku Cancer Center Hospital | Ehime | 790-0007 | Japan |
| National Hospital Organization - Nishigunma National Hospital | Gumna | 377-8511 | Japan |
| Gunma Cancer Center | Gunma | 373-8550 | Japan |
| National Hospital Organization - Dohoku National Hospital | Hokkaido | 070-0901 | Japan |
| Junshinkai Tsuna Hospital | Hyōgo | 663-8501 | Japan |
| Takarazuka Municipal Hospital | Hyōgo | 665-0827 | Japan |
| Fujisawa City Hospital | Kanagawa | 251-8550 | Japan |
| National Hospital Organization - Minamikyoto Medical Center | Kyoto | 610-0113 | Japan |
| Miyagi Cancer Center | Miyagi | 981-1293 | Japan |
| National Hospital Organization - Okayama Medical Center | Okayama | 701-1192 | Japan |
| Osaka Kosei Nenkin Hospital | Osaka | 553-0003 | Japan |
| Osaka General Medical Center | Osaka | 558-0056 | Japan |
| National Hospital Organization - Osaka National Hospital | Osaka | 591-8555 | Japan |
| Saitama Cardiovascular and Respiratory Center | Saitama | 360-0105 | Japan |
| Tokyo Medical University | Tokyo | 160 | Japan |
| Tottori University Hospital | Tottori | 683-8504 | Japan |
| Koseiren Takaoka Hospital | Toyama | 933-8555 | Japan |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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