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| ID | Type | Description | Link |
|---|---|---|---|
| JMTO-LC00-03 |
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RATIONALE: Drugs used in chemotherapy, such as vinorelbine, gemcitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying how well giving vinorelbine together with gemcitabine and docetaxel works compared to giving paclitaxel together with carboplatin in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 2 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| docetaxel | Drug | |||
| gemcitabine hydrochloride | Drug | |||
| paclitaxel | Drug | |||
| vinorelbine tartrate | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following:
The following cellular subtypes are allowed:
Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy
No known brain metastases by CT scan or MRI within the past 6 weeks
No pleural or pericardial effusions requiring treatment
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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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 |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Aichi | 466-8560 | Japan | |||
| Asahikawa Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19231158 | Result | Teramukai S, Kitano T, Kishida Y, Kawahara M, Kubota K, Komuta K, Minato K, Mio T, Fujita Y, Yonei T, Nakano K, Tsuboi M, Shibata K, Furuse K, Fukushima M. Pretreatment neutrophil count as an independent prognostic factor in advanced non-small-cell lung cancer: an analysis of Japan Multinational Trial Organisation LC00-03. Eur J Cancer. 2009 Jul;45(11):1950-8. doi: 10.1016/j.ejca.2009.01.023. Epub 2009 Feb 21. | |
| 19013107 |
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| Asahikawa |
| 078 8510 |
| Japan |
| National Cancer Center Hospital East | Chiba-ken | 277-8577 | Japan |
| National Hospital Organization - Ehime National Hospital | Ehime | 791-0281 | Japan |
| Aso Iizuka Hospital | Fukuoka | 820-0018 | Japan |
| National Hospital Organization - Medical Center of Kure | Hiroshima | 737-0023 | Japan |
| National Hospital Organization - Dohoku National Hospital | Hokkaido | 070-0901 | Japan |
| Fujisawa City Hospital | Kanagawa | 251-8550 | Japan |
| National Hospital Organization - Kochi Hospital | Kochi | 780-8065 | Japan |
| Kyoto-Katsura Hospital | Kyoto | 615-8256 | Japan |
| Ogaki Municipal Hospital | Ogaki-shi | 503-8502 | Japan |
| National Hospital Organization - Okayama Medical Center | Okayama | 701-1192 | Japan |
| National Hospital Organization - Okinawa Hospital | Okinawa | 901-2214 | Japan |
| Osaka Saiseikai Nakatsu Hospital | Osaka | 530-0012 | Japan |
| Osaka General Medical Center | Osaka | 558-0056 | Japan |
| Takatsuki Red Cross Hospital | Osaka | 569-1096 | Japan |
| National Hospital Organization - Osaka National Hospital | Osaka | 591-8555 | Japan |
| Saitama Cancer Center | Saitama | 362-0803 | Japan |
| Takamatsu Red Cross Hospital | Takamatsu | 760-8571 | Japan |
| Tokyo Medical and Dental University | Tokyo | 113-8519 | Japan |
| Tokyo Medical University | Tokyo | 160 | Japan |
| Tottori University Hospital | Tottori | 683-8504 | Japan |
| Toyama Medical and Pharmaceutical University Hospital | Toyama | 930-0194 | Japan |
| Koseiren Takaoka Hospital | Toyama | 933-8555 | Japan |
| Result |
| Kubota K, Kawahara M, Ogawara M, Nishiwaki Y, Komuta K, Minato K, Fujita Y, Teramukai S, Fukushima M, Furuse K; Japan Multi-National Trial Organisation. Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study. Lancet Oncol. 2008 Dec;9(12):1135-42. doi: 10.1016/S1470-2045(08)70261-4. Epub 2008 Nov 13. |
| Result | Teramukai S, Nishimura T, Nakagawa M, et al.: Predictors and impacts of second-line chemotherapy on survival after progression in patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7675, 2007. |
| 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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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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