[原创] 第三期 Amrubicin和 Cisplatin 治疗小细胞肺癌在中国招募志愿者

heping

http://clinicaltrials.gov/ct2/show/NCT00660504?recr=Open&cntry1=ES%3ACN&rank=4



Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-Cisplatin for Extensive Disease Small Cell Lung Cancer

This study is currently recruiting participants.
Verified by Sumiyaku China Co., Ltd., April 2008

Sponsored by:         Sumiyaku China Co., Ltd.
Information provided by:         Sumiyaku China Co., Ltd.
ClinicalTrials.gov Identifier:         NCT00660504
  Purpose

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer

Condition         Intervention         Phase
Lung Cancer
        Drug: Amrubicin Hydrochloride
Drug: Etoposide-Cisplatin combined chemotherapy
        Phase III

MedlinePlus related topics:           Cancer    Lung Cancer   

ChemIDplus related topics:           Etoposide    Cisplatin    Etoposide phosphate    Amrubicin   

U.S. FDA Resources

Study Type:           Interventional
Study Design:           Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:           Randomized, Open-Label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-Line Treatment in Patients With Extensive Disease SCLC

Further study details as provided by Sumiyaku China Co., Ltd.:

Primary Outcome Measures:

    * Overall survival [ Time Frame: 1.5 years after last subject first visit ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

    * Progression-Free survival; Objective response rate; Toxicity [ Time Frame: 1.5 years after last subject first visit ] [ Designated as safety issue: No ]


Estimated Enrollment:           300
Study Start Date:           April 2008
Estimated Study Completion Date:           December 2010
Estimated Primary Completion Date:           December 2010 (Final data collection date for primary outcome measure)

Arms         Assigned Interventions
1: Experimental
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
        Drug: Amrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
2: Active Comparator
Etoposide-Cisplatin combined chemotherapy
        Drug: Etoposide-Cisplatin combined chemotherapy
combined chemotherapy

  Eligibility
Ages Eligible for Study:           18 Years and older
Genders Eligible for Study:           Both
Accepts Healthy Volunteers:           No

Criteria

Inclusion Criteria:

    * Histologically/cytologically proven small cell lung cancer
    * Extensive disease
    * No prior chemotherapy regimen
    * Age 18 years or older
    * ECOG performance status of 0-1

Exclusion Criteria:

    * Brain metastasis requiring treatment
    * Treatment (Surgical or radiotherapy)of primary tumor
    * Interstitial pneumonia or pulmonary fibrosis
    * Abnormal cardiac function or myocardial infraction within 6 months before study enrollment

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660504

Contacts
Contact: Xiao-yan Luo, MD             +861066425188 ext 25            

Locations
China
                        Recruiting
              Beijing, China
                        Not yet recruiting
              Tianjin, China
                        Recruiting
              Shanghai, China
China, Fujian
                        Not yet recruiting
              Fuzhou, Fujian, China
China, Guangdong
                        Not yet recruiting
              Guangzhou, Guangdong, China
China, Hunan
                        Not yet recruiting
              Changsha, Hunan, China
China, Jiangsu
                        Not yet recruiting
              Nanjing, Jiangsu, China
China, Jiangxi
                        Recruiting
              Nanchang, Jiangxi, China
China, Jilin
                        Not yet recruiting
              Changchun, Jilin, China
China, Liaoning
                        Not yet recruiting
              Dalian/Shenyang, Liaoning, China
China, Shanxi
                        Not yet recruiting
              Xian, Shanxi, China
China, Sichuan
                        Not yet recruiting
              Chengdu, Sichuan, China
China, Zhejiang
                        Not yet recruiting
              Hangzhou, Zhejiang, China

Sponsors and Collaborators
Sumiyaku China Co., Ltd.

Investigators
Principal Investigator:             Yan Sun, MD             Cancer hospital, Chinese Academy of Medical Science   
  More Information

Responsible Party:           Sumiyaku China Co., Ltd. ( Xiao-yan Lou, The medical department head of Sumiyaku China )
Study ID Numbers:           D0750018, D0750018
First Received:           April 10, 2008
Last Updated:           April 21, 2008
ClinicalTrials.gov Identifier:           NCT00660504
Health Authority:           China: State Food and Drug Administration

Keywords provided by Sumiyaku China Co., Ltd.:
Extensive Disease-Small Cell Lung Cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Amrubicin
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
               
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
               
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 22, 2008

blessmydad

可惜申请已经截止了！