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

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.

Conditions

• Stage III Non-small-Cell Lung Cancer

Interventions

DRUG

Recombinant human endostatin

Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.

DRUG

Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles

DRUG

cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles

OTHER

laboratory biomarker analysis

OTHER

CT perfusion imaging

Sponsors & Collaborators

• Chinese Academy of Medical Sciences

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• The First People's Hospital of Lianyungang

  collaborator OTHER

• Zhejiang Cancer Hospital

  lead OTHER

Principal Investigators

• Ming Chen, M.D. · Zhejiang Cancer Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-11-30

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• China

Study Locations