Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
NCT ID: NCT01733589
Last Updated: 2017-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
73 participants
INTERVENTIONAL
2012-11-30
2015-06-30
Brief Summary
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Detailed Description
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Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
Secondary
Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.
Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Recombinant Human Endostatin
All patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60\~66Gy in 30\~33 fractions for 6\~7 weeks.
Recombinant human endostatin
Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.
Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles
cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles
laboratory biomarker analysis
CT perfusion imaging
Interventions
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Recombinant human endostatin
Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.
Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles
cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles
laboratory biomarker analysis
CT perfusion imaging
Eligibility Criteria
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Inclusion Criteria
* inoperable stage IIIA or IIIB NSCLC
* measurable disease by RECIST
* 18\~70 years of age
* an ECOG PS of 0 to 1
* absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
* serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
* bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
* forced vital capacity in 1 second (FEV1) higher than 0.8 L
* CB6 is normal
* Written informed consent
Exclusion Criteria
* any contraindications for chemoradiotherapy
* distant metastasis
* malignant pleural and/or pericardial effusion
* pregnant or nursing
* preexisting bleeding diatheses or coagulopathy
18 Years
70 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Fudan University
OTHER
Peking University Cancer Hospital & Institute
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Shandong Cancer Hospital and Institute
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Fujian Cancer Hospital
OTHER_GOV
The First People's Hospital of Lianyungang
OTHER
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Ming Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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[2012]-10-24
Identifier Type: -
Identifier Source: org_study_id
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