Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
Conditions
Stage III Non-small-Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Recombinant human endostatin, Non-small-Cell Lung Cancer, chemoradiotherapy
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Recombinant human endostatin
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Recruiting
Contact: Ming Chen, M.D. - 0086-571-88122068 - gzcm@263.net
Start Date
November 2012
Completion Date
May 2014
Sponsors
Zhejiang Cancer Hospital
Source
Zhejiang Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page