Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Fifth Affiliated Hospital, Sun Yat-Sen University; Fujian Province Tumor Hospital; Guangxi Medical University; Guangzhou General Hospital of Guangzhou Military Command; The 458 Hospital of Chinese PLA; The Affiliated Hospital of Guangdong Medical College; The Affiliated Tumor Hospital of Guangxi Medical University; Zhejiang Cancer Hospital
• Treatments: Endostatins

Criteria

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