Status:
UNKNOWN
Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Hospital of Guangdong Medical University
Fujian Province Tumor Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To 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).
Detailed Description
OBJECTIVES: 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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01218594
Start Date
May 1 2009
End Date
December 1 2015
Last Update
October 17 2012
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060