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Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Stage III Non-small-Cell Lung Cancer

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Trial Information

Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Description:

from beginning treatment to progressive disease or the last follow-up

Outcome Time Frame:

2-year

Safety Issue:

No

Principal Investigator

Ming Chen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Ethics Committee

Study ID:

[2012]-10-24

NCT ID:

NCT01733589

Start Date:

November 2012

Completion Date:

May 2014

Related Keywords:

  • Stage III Non-small-cell Lung Cancer
  • Recombinant human endostatin
  • Non-small-Cell Lung Cancer
  • chemoradiotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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