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Phase III Study of Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

Phase 3
18 Years
70 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

Phase III Study of Adjuvant Vinorelbine Plus Cisplatin (NP) Versus NP Plus Endostar in Patients With Completely Resected Stage IB-IIIA Non-small Cell Lung Cancer

It is an open labelled, randomized, mono-center phase III clinical trail.A total of 250
patients with resected stage IB to stage IIIA non-small cell lung cancer will either the
group of vinorelbine plus cisplatin plus endostar or the group of vinorelbine plus cisplatin
randomly. The primary end point was overall survival; principal secondary end points were
recurrence-free survival and the toxicity and safety of the regimens.The major inclusive
criteria are pathological confirmed non-small cell lung cancer after complete resection and
can tolerate chemotherapy safely.The tissue and blood samples will be banked for further
investigation. All of the enrolled patients will be followed up until death or over 5 years.

Inclusion Criteria:

- Histologically confirmed non-small cell lung cancer, the pathology type includes
squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, and any mixed type of
the 3 types mentioned above.

- Stage IB-IIIA non-small cell lung cancer, tumor was completely resected (The type of
surgery including lobectomy, left side pneumonectomy,bi-lobectomy).

- The time from surgery to first dose of adjuvant chemotherapy are mandatory between
4-8 weeks.

- No evidence of tumor relapse prior to adjuvant therapy.

- Age 18-70, Eastern Cooperative Oncology Group(ECOG) performance status 0-1.

- Normal hematologic function.Renal function , hepatic and cardiac function will be
within the acceptable ranges as following:serum bilirubin, aspartate
aminotransferase(AST)and alamine aminotransferase(ALT)levels below 1.5 times of
normal value.

- No history of chemotherapy or radiotherapy;

- The patient should have well compliance for chemotherapy and follow up

- Informed consent should be obtained before treatment.

Exclusion Criteria:

- The histological or cytological documents do not match the inclusion criteria.

- Right side pneumonectomy or any kind of incompletely resected surgery.

- The recruitment time are beyond 8 weeks from surgery.

- Any concurrent acute or chronic systemic diseases or psychiatric diseases, which
might both increase the risks of the research itself or the medical therapy and
influence the research results analysis. The researchers can make a judge for the
following conditions to tell whether they are fit for this research:Uncontrolled high
blood pressure, unstable angina , myocardial infarction , uncontrolled arrhythmia,or
congestive heart failure with clinical symptoms within 12 weeks before
randomization.Evidence of anemia from electrocardiographic manifestation or heart
valve disease with confirmed clinical diagnosis.Clinically significant active
infection state due to bacteria, virus and fungi invasion. Patients with grade II
arrhythmia, grade II myocardial anemia, grade II abnormal cardiac troponin T, grade
II high blood pressure or left ventricle ejection fraction (LVEF) less than 50
percent according to CTC 3.0 are not permitted to enrol the study.

- women with pregnant or lactation.

- Before enter the group,the patients had other malignant tumors except for
non-melanoma skin cancer, carcinoma in situ and cured early-stage prostate cancer.

- With allergic constitution or possible allergic reflection to any known research

- Poor compliance.

- Not proper for the research according to the researchers' judgment.

Type of Study:


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:

five years

Safety Issue:


Principal Investigator

Liao Meilin, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Shanghai Chest Hospital


China: Ethics Committee

Study ID:




Start Date:

July 2007

Completion Date:

October 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • adjuvant therapy
  • non-small cell lung cancer
  • vinorelbine
  • cisplatin
  • recombinant human endostatin
  • endostar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms