Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Sponsor||Sun Yat-sen University|
|Collaborator||Guangdong Medical College|
|Start date||May 2009|
|End date||December 2013|
|Trial size||50 participants|
|Trial identifier||NCT01218594, DP-EN-RT|
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).
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
Response Rate (RR)
time frame: 4 weeks after CCRT
Male or female participants from 18 years up to 75 years old.
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
|Official title||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|
|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 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.|
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