NCT00576914

Brief Summary

This study was designed to determine whether adjuvant vinorelbine plus cisplatin and endostar prolongs overall survival compare to vinorelbine plus cisplatin alone among patients with completely resected IB-IIIA non-small-cell lung cancer. The patients with completely resected stage IB to stage IIIA non-small cell lung cancer were randomly assigned to the group of vinorelbine plus cisplatin plus endostar or to the group of vinorelbine plus cisplatin . The primary end point was overall survival; principal secondary end points were recurrence-free survival and the toxicity and safety of the regimens.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,108

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 9, 2010

Status Verified

March 1, 2009

Enrollment Period

5 years

First QC Date

December 18, 2007

Last Update Submit

March 8, 2010

Conditions

Non-small Cell Lung Cancer

Keywords

adjuvant therapynon-small cell lung cancervinorelbinecisplatinrecombinant human endostatin(endostar)

Outcome Measures

Primary Outcomes (1)

  • overall survival

    five year

Secondary Outcomes (1)

  • recurrence-free survival and the toxicity and safety of the regimens

    5 year

Study Arms (2)

A

ACTIVE COMPARATOR

vinorelbine plus cisplatin plus recombinant human endostatin

Drug: recombinant human endostatin

B

NO INTERVENTION

vinorelbine plus cisplatin

Drug: recombinant human endostatin

Interventions

recombinant human endostatinDRUG

recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed

Also known as: endostar
AB

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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, ECOG performance status 0-1.
  • Normal hematologic function.Renal function , hepatic and cardiac function will be within the acceptable ranges as following:serum bilirubin, AST and 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.

You may not qualify if:

  • 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 drugs.
  • Poor compliance.
  • Not proper for the research according to the researchers' judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Lung Cancer Center of Cancer Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

  • Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X.

    PMID: 16945766BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Endostatinsendostar protein

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Study Officials

  • Jie He, M.D. & Ph.D.

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Xinling Liu, Bachelor

CONTACT

86-10-87788495liuxinling1985@126.com

Fang Li, M.D.

CONTACT

86-13910145882nc_lifang@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 9, 2010

Record last verified: 2009-03

Locations

CN(1)