Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
NCT ID: NCT01218594
Last Updated: 2012-10-17
Study Results
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View full resultsBasic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2009-05-31
2015-12-31
Brief Summary
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Detailed Description
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Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT
Secondary
* The progression-free survival (PFS)
* The overall survival(OS).
* The failed treatment modality.
* The toxicity of this regimen.
OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration\>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.
Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.
Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endostatin combine CCRT
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Endostatin
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Interventions
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Endostatin
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
* weight loss of less than 10% in the past 6 months
* performance status (PS) of 0 to 1
* forced vital capacity in 1 second (FEV1) higher than 0.8 L
* measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
* absolute neutrophil count (ANC) of ≥ 1500/μL
* hemoglobin ≥ 10 mg/dL
* platelet ≥ 100,000/μL
* serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
* calculated creatinine clearance (CrCl) of ≥ 60 ml/min
* bilirubin 1.5×ULN
* AST and ALT less than 2.5×ULN
* alkaline phosphatase less than 5×ULN.
Exclusion Criteria
* history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* malnutrition (loss of ≥ 20% of the original body weight)
* sensor or motor neuropathy \> grade I
* second primary malignancy, except for non-melanoma skin cancer
* psychiatric illness or social situation that would preclude study compliance
* pregnant or lactating women
* preexisting bleeding diatheses or coagulopathy
* Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
18 Years
75 Years
ALL
No
Sponsors
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Affiliated Hospital of Guangdong Medical University
OTHER
Fujian Province Tumor Hospital
OTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
The Affiliated Tumor Hospital of Guangxi Medical University
UNKNOWN
Zhejiang Cancer Hospital
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
The 458 Hospital of Chinese PLA
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming Chen
Professor
Principal Investigators
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Ming Chen, Doctor
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
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Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.
Other Identifiers
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DP-EN-RT
Identifier Type: -
Identifier Source: org_study_id