Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer

This study is currently recruiting participants.
Verified on January 2010 by Sun Yat-sen University

First Received on June 1, 2010.  
Last Updated on September 8, 2011  
History of Changes
This Clinical Trial Sponsored By: Sun Yat-sen University
Collaborators: Guangdong Medical College
Guangdong Pharmaceutical University
The 458 Hospital of Chinese PLA
Information provided by (Responsible Party): Ming Chen, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01218594
 

Purpose for Clinical Trial

To investigate the short-term effects and toxicity of Endostatin combined with concurrent three dimensional conformal radiotherapy (3D-CRT) and chemotherapy on locally advanced non-small cell lung cancer

Condition Study Intervention Clinical Trial Phase
Non-small Cell Lung Cancer Drug: Endostatin Phase II

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Endostatin Combined With Concurrent Chemoradiation for Unresectable Locally Advanced Non-small-cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lung Cancer
Drug Information available for:
Endostatin

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures For Clinical Trial:

  • The total short diameter of tumor [ Time Frame: 4 weeks after CCRT,then follow up once every 3 months ] [ Designated as safety issue: Yes ]
    Evaluate the diameter by Computed Tomography

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Endostatin combine CCRT: Experimental

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

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

Detailed Description:

OBJECTIVES:

Primary:To evaluate the progression-free survival of patients with locally advanced unresectable non-small cell lung cancer treated with Endostatin combined with concurrent three dimensional conformal radiotherapy and chemotherapy.

Secondary

  • The clinical remission rate.
  • The overall survival.
  • The failed treatment modality.
  • The toxicity of this regimen.

OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.

Endostatin:Patients receive Endostatin 7.5mg/m2 daily by iv gtt up to 7 days consecutively 1 week before radiotherapy and repeat every 2 weeks.

The curative effect is evaluated by Computed Tomography(CT) 4 weeks after completion CCRT.Patients are followed once every 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically confirmed, unresectable locally advanced (stage IIIA/IIIB) NSCLC
  • no previous therapy for NSCLC is allowed
  • bidimensionally measurable disease
  • performance status (WHO) 0-2
  • absence of pleural effusion
  • adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT < 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine < 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • life expectancy of more than 3 months
  • written informed consent

Exclusion Criteria:

  • 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)
  • performance status: 3-4
  • 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218594

Contacts
Contact: Ming Chen, Doctor 862061283621 chenming@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yong Bao     862061639573     baoyong@sysucc.org.cn    
Principal Investigator: Ming Chen, Doctor            
Sponsors and Collaborators
Sun Yat-sen University
Guangdong Medical College
Guangdong Pharmaceutical University
The 458 Hospital of Chinese PLA
Investigators
Study Chair: Ming Chen, Doctor Sun Yat-sen University

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