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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Collaborators: Beijing Cancer Hospital; Chinese Academy of Medical Sciences; Fudan University; Fujian Cancer Hospital; Jiangsu Cancer Institute & Hospital; Shandong Cancer Hospital and Institute; The First People's Hospital of Lianyungang; Tianjin Medical University Cancer Institute and Hospital
• Treatments: Cisplatin; Endostatins; Etoposide

Criteria

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