메뉴 건너뛰기




Volumn 103, Issue 14, 2011, Pages 1075-1077

More randomization in phase II Trials: Necessary but not sufficient

Author keywords

[No Author keywords available]

Indexed keywords

ARSENIC TRIOXIDE; IMATINIB; LENALIDOMIDE; RETINOIC ACID; RITUXIMAB; TRASTUZUMAB; VASCULOTROPIN INHIBITOR;

EID: 79960739368     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djr238     Document Type: Editorial
Times cited : (17)

References (41)
  • 3
    • 79960746726 scopus 로고    scopus 로고
    • Randomized phase II trials: A long-term investment with promising returns
    • Sharma MR, Stadler WM, Ratain MJ. Randomized phase II trials: a long-term investment with promising returns. J Natl Cancer Inst. 2011;103(14):1093-1100.
    • (2011) J Natl Cancer Inst , vol.103 , Issue.14 , pp. 1093-1100
    • Sharma, M.R.1    Stadler, W.M.2    Ratain, M.J.3
  • 4
    • 77951639219 scopus 로고    scopus 로고
    • Comparison of error rates in single-arm versus randomized phase II cancer clinical trials
    • Tang H, Foster NR, Grothey A, Ansell SM, Goldberg RM, Sargent DJ. Comparison of error rates in single-arm versus randomized phase II cancer clinical trials. J Clin Oncol. 2010;28(11):1936-1941.
    • (2010) J Clin Oncol , vol.28 , Issue.11 , pp. 1936-1941
    • Tang, H.1    Foster, N.R.2    Grothey, A.3    Ansell, S.M.4    Goldberg, R.M.5    Sargent, D.J.6
  • 5
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • DOI 10.1016/0197-2456(89)90015-9
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1-10. (Pubitemid 19099520)
    • (1989) Controlled Clinical Trials , vol.10 , Issue.1 , pp. 1-10
    • Simon, R.1
  • 7
    • 78149240696 scopus 로고    scopus 로고
    • Randomized phase II trials: Misleading and unreliable
    • Stewart DJ. Randomized phase II trials: misleading and unreliable. J Clin Oncol. 2010;28(31):e649-e650.
    • (2010) J Clin Oncol , vol.28 , Issue.31
    • Stewart, D.J.1
  • 8
    • 77949673913 scopus 로고    scopus 로고
    • The design of phase II clinical trials testing cancer therapeutics: Consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee
    • Seymour L, Ivy SP, Sargent D, et al. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res. 2010;16(6):1764-1769.
    • (2010) Clin Cancer Res , vol.16 , Issue.6 , pp. 1764-1769
    • Seymour, L.1    Ivy, S.P.2    Sargent, D.3
  • 10
    • 2442628111 scopus 로고    scopus 로고
    • Adjusted survival curves with inverse probability weights
    • DOI 10.1016/j.cmpb.2003.10.004, PII S0169260703001378
    • Cole SR, Hernan MA. Adjusted survival curves with inverse probability weights. Comput Methods Programs Biomed. 2004;75(1):45-49. (Pubitemid 38648876)
    • (2004) Computer Methods and Programs in Biomedicine , vol.75 , Issue.1 , pp. 45-49
    • Cole, S.R.1    Hernan, M.A.2
  • 12
    • 57849086172 scopus 로고    scopus 로고
    • Validation of novel imaging methodologies for use as cancer clinical trial end-points
    • Sargent DJ, Rubinstein L, Schwartz L, et al. Validation of novel imaging methodologies for use as cancer clinical trial end-points. Eur J Cancer. 2009;45(2):290-299.
    • (2009) Eur J Cancer , vol.45 , Issue.2 , pp. 290-299
    • Sargent, D.J.1    Rubinstein, L.2    Schwartz, L.3
  • 14
    • 42949145995 scopus 로고    scopus 로고
    • Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer
    • Burzykowski T, Buyse M, Piccart-Gebhart MJ, et al. Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. J Clin Oncol. 2008;26(12):1987-1992.
    • (2008) J Clin Oncol , vol.26 , Issue.12 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gebhart, M.J.3
  • 15
    • 75649152090 scopus 로고    scopus 로고
    • FDA drug approval summary: Bevacizumab plus interferon for advanced renal cell carcinoma
    • Summers J, Cohen MH, Keegan P, Pazdur R. FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma. Oncologist. 2010;15(1):104-111.
    • (2010) Oncologist , vol.15 , Issue.1 , pp. 104-111
    • Summers, J.1    Cohen, M.H.2    Keegan, P.3    Pazdur, R.4
  • 16
    • 33846440150 scopus 로고    scopus 로고
    • Food and Drug Administration drug approval summary: Sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma
    • DOI 10.1634/theoncologist.12-1-107
    • Rock EP, Goodman V, Jiang JX, et al. Food and Drug Administration drug approval summary: sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma. Oncologist. 2007;12(1):107-113. (Pubitemid 46143508)
    • (2007) Oncologist , vol.12 , Issue.1 , pp. 107-113
    • Rock, E.P.1    Goodman, V.2    Jiang, J.X.3    Mahjoob, K.4    Verbois, S.L.5    Morse, D.6    Dagher, R.7    Justice, R.8    Pazdur, R.9
  • 18
    • 79959796486 scopus 로고    scopus 로고
    • NICE guidance on pazopanib for first-line treatment of advanced renal-cell carcinoma
    • Griffiths C, Hay N, Sutcliffe F, Stevens A. NICE guidance on pazopanib for first-line treatment of advanced renal-cell carcinoma. Lancet Oncol. 2011;12(3):221-222.
    • (2011) Lancet Oncol , vol.12 , Issue.3 , pp. 221-222
    • Griffiths, C.1    Hay, N.2    Sutcliffe, F.3    Stevens, A.4
  • 20
    • 77949890945 scopus 로고    scopus 로고
    • Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase III trial
    • Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010;28(6):1061-1068.
    • (2010) J Clin Oncol , vol.28 , Issue.6 , pp. 1061-1068
    • Sternberg, C.N.1    Davis, I.D.2    Mardiak, J.3
  • 21
    • 77955393886 scopus 로고    scopus 로고
    • The evolving field of tyrosine kinase inhibitors in the treatment of endocrine tumors
    • Ye L, Santarpia L, Gagel RF. The evolving field of tyrosine kinase inhibitors in the treatment of endocrine tumors. Endocr Rev. 2010;31(4):578-599.
    • (2010) Endocr Rev , vol.31 , Issue.4 , pp. 578-599
    • Ye, L.1    Santarpia, L.2    Gagel, R.F.3
  • 22
    • 77957359933 scopus 로고    scopus 로고
    • Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: Results of a phase 2 consortium study
    • Bible KC, Suman VJ, Molina JR, et al. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010;11(10):962-972.
    • (2010) Lancet Oncol , vol.11 , Issue.10 , pp. 962-972
    • Bible, K.C.1    Suman, V.J.2    Molina, J.R.3
  • 23
    • 77954700380 scopus 로고    scopus 로고
    • Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer
    • Miles DW, Chan A, Dirix LY, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010;28(20):3239-3247.
    • (2010) J Clin Oncol , vol.28 , Issue.20 , pp. 3239-3247
    • Miles, D.W.1    Chan, A.2    Dirix, L.Y.3
  • 24
    • 79953874259 scopus 로고    scopus 로고
    • RIBBON-1: Randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer
    • Robert NJ, Dieras V, Glaspy J, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011;29(10):1252-1260.
    • (2011) J Clin Oncol , vol.29 , Issue.10 , pp. 1252-1260
    • Robert, N.J.1    Dieras, V.2    Glaspy, J.3
  • 25
    • 77951473661 scopus 로고    scopus 로고
    • Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: Results from a randomised phase III trial (AVAiL)
    • Reck M, von PJ, Zatloukal P, et al. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010;21(9):1804-1809.
    • (2010) Ann Oncol , vol.21 , Issue.9 , pp. 1804-1809
    • Reck, M.1    Von Pj Zatloukal, P.2
  • 26
    • 77955887676 scopus 로고    scopus 로고
    • Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: Phase III trial of the Cancer and Leukemia Group B (CALGB 80303)
    • Kindler HL, Niedzwiecki D, Hollis D, et al. Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: phase III trial of the Cancer and Leukemia Group B (CALGB 80303). J Clin Oncol. 2010;28(22):3617-3622.
    • (2010) J Clin Oncol , vol.28 , Issue.22 , pp. 3617-3622
    • Kindler, H.L.1    Niedzwiecki, D.2    Hollis, D.3
  • 27
    • 65549150854 scopus 로고    scopus 로고
    • Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer
    • Van CE, Vervenne WL, Bennouna J, et al. Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. J Clin Oncol. 2009;27(13):2231-2237.
    • (2009) J Clin Oncol , vol.27 , Issue.13 , pp. 2231-2237
    • Van, C.E.1    Vervenne, W.L.2    Bennouna, J.3
  • 28
    • 79952173475 scopus 로고    scopus 로고
    • The efficacy of cediranib as monotherapy and in combination with lomustine compared to lomustine alone in patients with recurrent glioblastoma-A phase III randomized study
    • Abstract 0T-25
    • Batchelor T, Mulholland P, Neyns B, et al. The efficacy of cediranib as monotherapy and in combination with lomustine compared to lomustine alone in patients with recurrent glioblastoma-A phase III randomized study. Neuro-Oncology. 2010;12(Suppl 4): Abstract 0T-25.
    • (2010) Neuro-Oncology , vol.12 , Issue.SUPPL 4
    • Batchelor, T.1    Mulholland, P.2    Neyns, B.3
  • 29
    • 79956299718 scopus 로고    scopus 로고
    • Cediranib + FOLFOX/XELOX versus placebo + FOLFOX/XELOX in patients (pts) with previously untreated metastatic colorectal cancer (MCRC): A randomized, double-blind, phase III study (Horizon II)
    • Hoff PM, Hochhaus A, Pestalozzi BC, et al. Cediranib + FOLFOX/XELOX versus placebo + FOLFOX/XELOX in patients (pts) with previously untreated metastatic colorectal cancer (MCRC): a randomized, double-blind, phase III study (Horizon II). Ann Oncol. 2010;21(Suppl 8):viii9.
    • (2010) Ann Oncol , vol.21 , Issue.SUPPL 8
    • Hoff, P.M.1    Hochhaus, A.2    Pestalozzi, B.C.3
  • 30
    • 79956334386 scopus 로고    scopus 로고
    • Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma
    • Hecht JR, Trarbach T, Hainsworth JD, et al. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011;29(15):1997-2003.
    • (2011) J Clin Oncol. , vol.29 , Issue.15 , pp. 1997-2003
    • Hecht, J.R.1    Trarbach, T.2    Hainsworth, J.D.3
  • 31
    • 79551521053 scopus 로고    scopus 로고
    • Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: Results of NSABP protocol C-08
    • Allegra CJ, Yothers G, O'Connell MJ, et al. Phase III trial assessing bevacizumab in stages II and III carcinoma of the colon: results of NSABP protocol C-08. J Clin Oncol. 2011;29(1):11-16.
    • (2011) J Clin Oncol , vol.29 , Issue.1 , pp. 11-16
    • Allegra, C.J.1    Yothers, G.2    O'Connell, M.J.3
  • 33
    • 77958456360 scopus 로고    scopus 로고
    • Arsenic trioxide improves event-free and overall survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710
    • Powell BL, Moser B, Stock W, et al. Arsenic trioxide improves event-free and overall survival for adults with acute promyelocytic leukemia: North American Leukemia Intergroup Study C9710. Blood. 2010;116(19):3751-3757.
    • (2010) Blood , vol.116 , Issue.19 , pp. 3751-3757
    • Powell, B.L.1    Moser, B.2    Stock, W.3
  • 37
    • 70449711127 scopus 로고    scopus 로고
    • Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: A children's oncology group study
    • Schultz KR, Bowman WP, Aledo A, et al. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a children's oncology group study. J Clin Oncol. 2009;27(31):5175-5181.
    • (2009) J Clin Oncol , vol.27 , Issue.31 , pp. 5175-5181
    • Schultz, K.R.1    Bowman, W.P.2    Aledo, A.3
  • 38
    • 77957200763 scopus 로고    scopus 로고
    • Long-term outcome of patients in the LNH-98.5 trial the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: A study by the Groupe d'Etudes des Lymphomes de l'Adulte
    • Coiffier B, Thieblemont C, Van Den Neste E, et al. Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by the Groupe d'Etudes des Lymphomes de l'Adulte. Blood. 2010;116(12):2040-2045.
    • (2010) Blood , vol.116 , Issue.12 , pp. 2040-2045
    • Coiffier, B.1    Thieblemont, C.2    Van Den Neste, E.3
  • 39
    • 33646004738 scopus 로고    scopus 로고
    • CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: A randomised controlled trial by the MabThera International Trial (MInT) Group
    • Pfreundschuh M, Trumper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7(5):379-391.
    • (2006) Lancet Oncol , vol.7 , Issue.5 , pp. 379-391
    • Pfreundschuh, M.1    Trumper, L.2    Osterborg, A.3
  • 41
    • 79960725350 scopus 로고    scopus 로고
    • Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB ECOG BMT-CTN 100104
    • McCarthy P, Owzar K, Anderson K, et al.Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous stem cell transplant (ASCT) for multiple myeloma (MM): CALGB ECOG BMT-CTN 100104. Haematologica. 2011;96(s1):S23.
    • (2011) Haematologica. , vol.96 , Issue.S1
    • McCarthy, P.1    Owzar, K.2    Anderson, K.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.