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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01218594 |
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Date of registration:
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01/06/2010 |
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Primary sponsor: |
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Public title:
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Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
DP-EN-RT |
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Scientific title:
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Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01218594 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Ming Chen, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sun Yat-sen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years of age
- 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:
- active infection
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-small Cell Lung Cancer
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Intervention(s)
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Drug: Endostatin
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Primary Outcome(s)
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The total short diameter of tumor
[Time Frame: 4 weeks after CCRT,then follow up once every 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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