Status:
UNKNOWN
Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Simcere Pharmaceutical Co., Ltd
Collaborating Sponsors:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cance...
Eligibility Criteria
Inclusion
- Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;
- Patients with ages of 18\~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss \<10% during last 6 months;
- CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）
- No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC\> 4.0 × 109 / L, absolute neutrophil count \> 1.5 × 109 / L, platelet count\> 100 × 109 / L, hemoglobin\> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 \> 1L or\> 40% of predicted value;
- Patients could understand the circumstances of this study and those who have signed the informed consent form;
Exclusion
- Pregnant or lactating women; women of child-bearing age without contraception;
- Acute infection or other serious underlying diseases;
- Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;
- Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;
- Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);
- Patients who are allergic to E. coli preparation;
- Patients who are unsuitable to participate in this trial determined by the researchers.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01211002
Start Date
October 1 2010
End Date
December 1 2012
Last Update
September 29 2010
Active Locations (1)
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1
Daping Hospital
Chongqin, China