Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer.
Rationale and design of decision: a double-blind, randomized, placebo-controlled phase III trial evaluating the efficacy and safety of sorafenib in patients with locally advanced or metastatic radioactive iodine (RAI)-refractory, differentiated thyroid cancer.
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DOI：
10.1186/1471-2407-11-349
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发表时间：
2011-08-11
期刊：
影响因子：
3.8
通讯作者：
Schlumberger M
中科院分区：
文献类型：
--
作者：
Brose MS;Nutting CM;Sherman SI;Shong YK;Smit JW;Reike G;Chung J;Kalmus J;Kappeler C;Schlumberger M
在全球范围内，甲状腺癌的发病率和死于这种疾病的患者人数正在增加。分化型甲状腺癌（DTC）是大多数患者中存在的组织学亚型，是甲状腺癌总发病率增加的主要原因。索拉非尼是一种多激酶抑制剂，靶向几个被认为参与甲状腺癌发病机制的分子信号，包括那些与DTC有关的分子信号。在DTC患者的II期研究中，索拉非尼治疗的中位无进展生存期（PFS）为58至84周，疾病控制率为59%至100%。DECISION试验旨在评估索拉非尼改善局部晚期或转移性放射性碘（RAI）难治性DTC患者PFS的能力。DECISION是一项多中心、双盲、随机、安慰剂对照的III期研究，研究对象是局部晚期/转移性rai难治性DTC患者。研究治疗将继续进行，直到影像学记录疾病进展、不可接受的毒性、不依从性或撤回同意。疗效将每56天（2个周期）评估一次，而安全性将在前8个月每28天（1个周期）评估一次，之后每56天评估一次。随着疾病进展，患者可以继续或开始使用索拉非尼，这取决于他们是随机接受索拉非尼还是安慰剂，由研究者自行决定。最初随机分配接受索拉非尼的患者将每3个月随访一次总生存期（OS）；最初随机分配接受安慰剂的患者将在交叉到索拉非尼后每月随访8个月。试验持续时间预计为30个月，从第一个患者被随机分配到计划的PFS事件数。主要终点为PFS；次要终点包括生存期、疾病进展时间、疾病控制率、反应率、反应持续时间、安全性和药代动力学分析。DECISION研究旨在测试索拉非尼是否能改善局部晚期或转移性rai难治性DTC患者的PFS。ClinicalTrials.gov标识符：NCT00984282；EudraCT: 2009-012007-25。
The incidence of thyroid cancer and the number of patients who die from this disease are increasing globally. Differentiated thyroid cancer (DTC) is the histologic subtype present in most patients and is primarily responsible for the increased overall incidence of thyroid cancer. Sorafenib is a multikinase inhibitor that targets several molecular signals believed to be involved in the pathogenesis of thyroid cancer, including those implicated in DTC. In phase II studies of patients with DTC, sorafenib treatment has yielded a median progression-free survival (PFS) of 58 to 84 weeks and disease control rates of 59% to 100%. The DECISION trial was designed to assess the ability of sorafenib to improve PFS in patients with locally advanced or metastatic, radioactive iodine (RAI)-refractory DTC. DECISION is a multicenter, double-blind, randomized, placebo-controlled phase III study in patients with locally advanced/metastatic RAI-refractory DTC. Study treatment will continue until radiographically documented disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent. Efficacy will be evaluated every 56 days (2 cycles), whereas safety will be evaluated every 28 days (1 cycle) for the first 8 months and every 56 days thereafter. Following disease progression, patients may continue or start sorafenib, depending on whether they were randomized to receive sorafenib or placebo, at investigator discretion. Patients originally randomized to receive sorafenib will be followed up every 3 months for overall survival (OS); patients originally randomized to receive placebo will be followed up every month for 8 months after cross-over to sorafenib. The duration of the trial is expected to be 30 months from the time the first patient is randomized until the planned number of PFS events is attained. The primary endpoint is PFS; secondary endpoints include OS, time to disease progression, disease control rate, response rate, duration of response, safety, and pharmacokinetic analysis. The DECISION study has been designed to test whether sorafenib improves PFS in patients with locally advanced or metastatic RAI-refractory DTC. ClinicalTrials.gov Identifier: NCT00984282; EudraCT: 2009-012007-25.
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影响因子：
11.5
作者：
Keefe, Stephen M.;Cohen, Marc A.;Brose, Marcia S.
通讯作者：
Brose, Marcia S.
DOI：
10.1093/jnci/92.3.205
发表时间：
2000-02-02
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
Therasse, P;Arbuck, SG;Gwyther, SG
通讯作者：
Gwyther, SG
影响因子：
254.7
作者：
Siegel, Rebecca L.;Miller, Kimberly D.;Jemal, Ahmedin
通讯作者：
Jemal, Ahmedin
影响因子：
45.3
作者：
Kloos, Richard T.;Ringel, Matthew D.;Shah, Manisha H.
通讯作者：
Shah, Manisha H.
影响因子：
11.2
作者：
Ricarte-Filho JC;Ryder M;Chitale DA;Rivera M;Heguy A;Ladanyi M;Janakiraman M;Solit D;Knauf JA;Tuttle RM;Ghossein RA;Fagin JA
通讯作者：
Fagin JA