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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-IPR-14005500 |
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Date of registration:
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2014-11-14 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Recombinant Mutated Human TNF in Combination?with Docetaxel and Carboplatin/Cisplatin in Patients with Stage IIIB/IV Non-Small-Cell Lung Cancer: A Randomized, Phase III Study
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Scientific title:
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Recombinant Mutated Human TNF in Combination?with Docetaxel and Carboplatin/Cisplatin in Patients with Stage IIIB/IV Non-Small-Cell Lung Cancer: A Randomized, Phase III Study |
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Date of first enrolment:
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2002-11-01 |
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Target sample size:
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A:300;B:300; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=9867 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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III (Phase III study)
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Countries of recruitment
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China
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Contacts
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Name:
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Meng Li
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Address:
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The Fourth Military Medical University, Xi'an, China
710032
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Telephone:
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+86 13299051978 |
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Email:
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lemon781106@hotmail.com |
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Affiliation:
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Biotechnology Center, The Fourth Military Medical University |
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Name:
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Yingqi Zhang
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Address:
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The Fourth Military Medical University, Xi'an, China
710032
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Telephone:
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+86 13809188261 |
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Email:
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zhangyqh@fmmu.edu.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Eligible patients (older than 18 years) were required to have histologically or cytologically con?rmed stage IIIB/IV NSCLC. Other inclusion criteria were measurable lesions as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 3.0), an European Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1, predicted life expectancy longer than at least 12weeks from ?rst study-drug dose, and adequate hematologic, hepatic, cardiac and renal function. A washout period from previous treatments was required (2 to 6 weeks).
Exclusion criteria: Exclusion criteria included hemoptysis (1/2 tsp or more per event); central nervous system metastases; pregnancy or lactation; a history of documented hemorrhagic diathesis or coagulopathy; therapeutic anticoagulation; regular use of aspirin (more than 325 mg per day), nonsteroidal antiinflammatory agents, or other agents known to inhibit platelet function; a history of hypersensitivity to paclitaxel, polypeptide drugs or biologics; and previous exposure to taxanes.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Lung Cancer
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Intervention(s)
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A:docetaxel and platinum;B:chemotherapy plus rmhTNF;
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Primary Outcome(s)
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responds survival;
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Source(s) of Monetary Support
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New Taihe Biopharmaceutical Co., Ltd., Guangzhou, China
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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