Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

Zhejiang Cancer Hospital73 enrolled

Overview

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Primary 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stage III Non-small-Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * untreated histologic or cytologic of NSCLC verified * 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: * a history of other malignant diseases * any contraindications for chemoradiotherapy * distant metastasis * malignant pleural and/or pericardial effusion * pregnant or nursing * preexisting bleeding diatheses or coagulopathy

Outcomes

Primary Outcomes

progression-free survival

from beginning treatment to progressive disease or the last follow-up

Time frame: 2-year

Secondary Outcomes

Response rate

complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)

Time frame: 1 month

overall survival

from date of beginning treatment until date of death

Time frame: 5 years

treatment related toxicities

radiation-induced esophagitis; radiation-induced pneumonia

Time frame: 3 months