Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use 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 for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Compare the effects of paclitaxel and carboplatin with or without tirapazamine on progression-free survival and overall survival in patients with stage IV and selected stage IIIB non-small cell lung cancer.
- Compare response rates in patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to weight loss (less than 5% vs 5% or more), stage of disease (IIIB vs IV), and lactate dehydrogenase level (normal vs abnormal). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
- Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for one year, and then every 6 months for 2 years, or until death.
PROJECTED ACCRUAL: Approximately 500 patients (250 per arm) will be accrued for this study within 20 months.
研究の種類
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Mobile、Alabama、アメリカ、36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix、Arizona、アメリカ、85006-2726
- CCOP - Greater Phoenix
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Phoenix、Arizona、アメリカ、85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson、Arizona、アメリカ、85724
- Arizona Cancer Center
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Tucson、Arizona、アメリカ、85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- University of Arkansas for Medical Sciences
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Little Rock、Arkansas、アメリカ、72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte、California、アメリカ、91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles、California、アメリカ、90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Martinez、California、アメリカ、94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland、California、アメリカ、94609-3305
- CCOP - Bay Area Tumor Institute
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Orange、California、アメリカ、92868
- Chao Family Comprehensive Cancer Center
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Sacramento、California、アメリカ、95817
- University of California Davis Cancer Center
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San Francisco、California、アメリカ、94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa、California、アメリカ、95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base、California、アメリカ、94535
- David Grant Medical Center
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Colorado
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Denver、Colorado、アメリカ、80220
- Veterans Affairs Medical Center - Denver
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Denver、Colorado、アメリカ、80010
- University of Colorado Cancer Center
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Georgia
-
Atlanta、Georgia、アメリカ、30342-1701
- CCOP - Atlanta Regional
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Fort Gordon、Georgia、アメリカ、30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu、Hawaii、アメリカ、96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago、Illinois、アメリカ、60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago、Illinois、アメリカ、60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur、Illinois、アメリカ、62526
- CCOP - Central Illinois
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Hines、Illinois、アメリカ、60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
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Iowa
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Bettendorf、Iowa、アメリカ、52722
- Hematology Oncology Associates of the Quad Cities
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Kansas
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Kansas City、Kansas、アメリカ、66160-7357
- University of Kansas Medical Center
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Wichita、Kansas、アメリカ、67214-3882
- CCOP - Wichita
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Wichita、Kansas、アメリカ、67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington、Kentucky、アメリカ、40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington、Kentucky、アメリカ、40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane University School of Medicine
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New Orleans、Louisiana、アメリカ、70112
- MBCCOP - LSU Health Sciences Center
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Shreveport、Louisiana、アメリカ、71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport、Louisiana、アメリカ、71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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Jamaica Plain、Massachusetts、アメリカ、02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor、Michigan、アメリカ、48105
- Veterans Affairs Medical Center - Ann Arbor
-
Ann Arbor、Michigan、アメリカ、48106
- CCOP - Ann Arbor Regional
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Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
-
Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Detroit、Michigan、アメリカ、48201-1932
- Veterans Affairs Medical Center - Detroit
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Southfield、Michigan、アメリカ、48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth、Minnesota、アメリカ、55805
- CCOP - Duluth
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Mississippi
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Biloxi、Mississippi、アメリカ、39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson、Mississippi、アメリカ、39216-4505
- University of Mississippi Medical Center
-
Jackson、Mississippi、アメリカ、39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB、Mississippi、アメリカ、39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City、Missouri、アメリカ、64128
- Veterans Affairs Medical Center - Kansas City
-
Kansas City、Missouri、アメリカ、64131
- CCOP - Kansas City
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Saint Louis、Missouri、アメリカ、63110-0250
- St. Louis University Health Sciences Center
-
Saint Louis、Missouri、アメリカ、63141
- CCOP - St. Louis-Cape Girardeau
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Springfield、Missouri、アメリカ、65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings、Montana、アメリカ、59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque、New Mexico、アメリカ、87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque、New Mexico、アメリカ、87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany、New York、アメリカ、12208
- Veterans Affairs Medical Center - Albany
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New York、New York、アメリカ、10032
- Herbert Irving Comprehensive Cancer Center
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Rochester、New York、アメリカ、14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati、Ohio、アメリカ、45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati、Ohio、アメリカ、45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、アメリカ、43206
- CCOP - Columbus
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Dayton、Ohio、アメリカ、45428
- Veterans Affairs Medical Center - Dayton
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Kettering、Ohio、アメリカ、45429
- CCOP - Dayton
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Toledo、Ohio、アメリカ、43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- Oklahoma Medical Research Foundation
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Oklahoma City、Oklahoma、アメリカ、73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland、Oregon、アメリカ、97207
- Veterans Affairs Medical Center - Portland
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Portland、Oregon、アメリカ、97213
- CCOP - Columbia River Program
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Portland、Oregon、アメリカ、97201-3098
- Oregon Cancer Center
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South Carolina
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Charleston、South Carolina、アメリカ、29425-0721
- Medical University of South Carolina
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Charleston、South Carolina、アメリカ、29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville、South Carolina、アメリカ、29615
- CCOP - Greenville
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Spartanburg、South Carolina、アメリカ、29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston、Texas、アメリカ、78234
- Brooke Army Medical Center
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Galveston、Texas、アメリカ、77555-0209
- University of Texas Medical Branch
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Houston、Texas、アメリカ、77030
- Veterans Affairs Medical Center - Houston
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San Antonio、Texas、アメリカ、78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio、Texas、アメリカ、78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple、Texas、アメリカ、76504
- Veterans Affairs Medical Center - Temple
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Temple、Texas、アメリカ、76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City、Utah、アメリカ、84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute
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Washington
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Seattle、Washington、アメリカ、98101
- CCOP - Virginia Mason Research Center
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Seattle、Washington、アメリカ、98104
- Swedish Cancer Institute
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Seattle、Washington、アメリカ、98108
- Veterans Affairs Medical Center - Seattle
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Tacoma、Washington、アメリカ、98431-5000
- Madigan Army Medical Center
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Tacoma、Washington、アメリカ、98405-0986
- CCOP - Northwest
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Histologically or cytologically proven newly diagnosed advanced primary non-small cell lung cancer (NSCLC), including the following cellular types:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unspecified carcinoma OR
- Recurrent disease after prior surgery and/or radiotherapy
Stage IIIB disease
- T4 lesion due to malignant pleural effusion OR
Stage IV disease
- Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the ipsilateral lung)
Measurable or evaluable disease
- Pleural effusions, ascites, and laboratory parameters not considered as only evidence of disease
- Must be outside prior radiated field or area of prior surgical resection or new lesion must be present
- No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT or SGPT no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
Renal:
- Creatinine no greater than ULN
- Creatinine clearance at least 50 mL/min
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No peripheral neuropathy (motor or sensory) of grade 2 or greater
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I/II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for NSCLC
Chemotherapy:
- No prior systemic chemotherapy for NSCLC
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior thoracic or other major surgery and recovered
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
協力者と研究者
スポンサー
捜査官
- スタディチェア:Stephen K. Williamson, MD、University of Kansas
出版物と役立つリンク
一般刊行物
- Lara PN Jr, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR; Southwest Oncology Group. Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008 Jan 20;26(3):463-7. doi: 10.1200/JCO.2007.13.0344.
- Lara PN Jr, Redman MW, Kelly K, et al.: Alternative measures predicting clinical benefit in advanced non-small cell lung cancer (NSCLC) from Southwest Oncology Group (SWOG) randomized trials: implications for clinical trial design. [Abstract] J Clin Oncol 24 (Suppl 18): A-7006, 365s, 2006.
- Gandara DR, Kawaguchi T, Crowley J, Moon J, Furuse K, Kawahara M, Teramukai S, Ohe Y, Kubota K, Williamson SK, Gautschi O, Lenz HJ, McLeod HL, Lara PN Jr, Coltman CA Jr, Fukuoka M, Saijo N, Fukushima M, Mack PC. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol. 2009 Jul 20;27(21):3540-6. doi: 10.1200/JCO.2008.20.8793. Epub 2009 May 26.
- Mack PC, Redman MW, Chansky K, Williamson SK, Farneth NC, Lara PN Jr, Franklin WA, Le QT, Crowley JJ, Gandara DR; SWOG. Lower osteopontin plasma levels are associated with superior outcomes in advanced non-small-cell lung cancer patients receiving platinum-based chemotherapy: SWOG Study S0003. J Clin Oncol. 2008 Oct 10;26(29):4771-6. doi: 10.1200/JCO.2008.17.0662. Epub 2008 Sep 8.
- Mack PC, Redman MW, Chansky K, et al.: Elevated osteopontin (OPN) plasma levels are highly prognostic in advanced non-small cell lung cancer (NSCLC): analysis of SWOG S0003. [Abstract] J Clin Oncol 24 (Suppl 18): A-7198, 413s, 2006.
- Williamson SK, Crowley JJ, Lara PN Jr, McCoy J, Lau DH, Tucker RW, Mills GM, Gandara DR; Southwest Oncology Group Trial S0003. Phase III trial of paclitaxel plus carboplatin with or without tirapazamine in advanced non-small-cell lung cancer: Southwest Oncology Group Trial S0003. J Clin Oncol. 2005 Dec 20;23(36):9097-104. doi: 10.1200/JCO.2005.01.3771.
- Kimura T, Holland WS, Kawaguchi T, Williamson SK, Chansky K, Crowley JJ, Doroshow JH, Lenz HJ, Gandara DR, Gumerlock PH. Mutant DNA in plasma of lung cancer patients: potential for monitoring response to therapy. Ann N Y Acad Sci. 2004 Jun;1022:55-60. doi: 10.1196/annals.1318.010.
- Williamson SK, Crowley JJ, Lara PN, et al.: S0003: paclitaxel/carboplatin (PC) versus PC + tirapazamine (PCT) in advanced non-small cell lung cancer (NSCLC). A phase III Southwest Oncology Group (SWOG) trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-89, S29, 2003.
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000068315
- SWOG-S0003
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
肺癌の臨床試験
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
カルボプラチンの臨床試験
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
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Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド