NCT01218594

Brief Summary

To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

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
50

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

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

May 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 17, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 17, 2012

Status Verified

August 1, 2012

Enrollment Period

4.6 years

First QC Date

June 1, 2010

Results QC Date

August 19, 2012

Last Update Submit

September 17, 2012

Conditions

Non-small Cell Lung Cancer

Keywords

Stage IIIUnresectableNon-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Response Rate (RR)

    Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).

    4 weeks after CCRT

Study Arms (1)

Endostatin combine CCRT

EXPERIMENTAL

7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Drug: Endostatin

Interventions

EndostatinDRUG

7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks

Also known as: Endostar
Endostatin combine CCRT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
  • weight loss of less than 10% in the past 6 months
  • performance status (PS) of 0 to 1
  • forced vital capacity in 1 second (FEV1) higher than 0.8 L
  • measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
  • absolute neutrophil count (ANC) of ≥ 1500/μL
  • hemoglobin ≥ 10 mg/dL
  • platelet ≥ 100,000/μL
  • serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
  • calculated creatinine clearance (CrCl) of ≥ 60 ml/min
  • bilirubin 1.5×ULN
  • AST and ALT less than 2.5×ULN
  • alkaline phosphatase less than 5×ULN.

You may not qualify if:

  • active infection
  • history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • malnutrition (loss of ≥ 20% of the original body weight)
  • sensor or motor neuropathy \> grade I
  • second primary malignancy, except for non-melanoma skin cancer
  • psychiatric illness or social situation that would preclude study compliance
  • pregnant or lactating women
  • preexisting bleeding diatheses or coagulopathy
  • Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • Bao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9.

    PMID: 25497558DERIVED

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

Limitations and Caveats

This was a single-arm study, no comparison between Endostar to CCRT and CCRT alone was performed. It is not clear whether the observed improvement in survival is a result of the addition of Endostar or patient selection.The patient samples are small.

Results Point of Contact

Title
Ming Chen
Organization
Sun Yat-Sen University Cancer Center
chenming@sysucc.org.cn
86-20-87343640

Study Officials

  • Ming Chen, Doctor

    Sun Yat-sen University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2010

First Posted

October 11, 2010

Study Start

May 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

October 17, 2012

Results First Posted

October 17, 2012

Record last verified: 2012-08

Locations

CN(1)