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The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )


Phase 4
18 Years
75 Years
Not Enrolling
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

The Exploratory Clinical Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin (Endostar) for Local Advanced Non-small Cell Lung Cancer (NSCLC (Ⅲ A / Ⅲ B) )


Inclusion Criteria:



1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A
or unresectable Ⅲ B) NSCLC;

2. Patients with ages of 18~70 years, general condition ECOG performance scale (PS)≤ 1,
weight loss <10% during last 6 months;

3. 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.)

4. 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;

5. Patients could understand the circumstances of this study and those who have signed
the informed consent form;

Exclusion Criteria:

1. Pregnant or lactating women; women of child-bearing age without contraception;

2. Acute infection or other serious underlying diseases;

3. Significant neurological, psychiatric history, including dementia which may influence
the ability to understand and the informed consent;

4. 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;

5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after
administration);

6. Patients who are allergic to E. coli preparation;

7. Patients who are unsuitable to participate in this trial determined by the
researchers.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival (OS)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

zhenzhou yang, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Daping hospital

Authority:

China: Food and Drug Administration

Study ID:

sim201002

NCT ID:

NCT01211002

Start Date:

October 2010

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Radiotherapy
  • rh-endostatin
  • chemotherapy
  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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