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Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer (DP-EN-RT)

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ClinicalTrials.gov Identifier: NCT01218594
Recruitment Status : Unknown
Verified August 2012 by Ming Chen, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : October 11, 2010
Results First Posted : October 17, 2012
Last Update Posted : October 17, 2012
Sponsor:
Collaborators:
The Affiliated Hospital of Guangdong Medical College
Fujian Province Tumor Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangxi Medical University
Zhejiang Cancer Hospital
Guangzhou General Hospital of Guangzhou Military Command
The 458 Hospital of Chinese PLA
Information provided by (Responsible Party):
Ming Chen, Sun Yat-sen University

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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Endostatin Phase 2

Detailed Description:

OBJECTIVES:

Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT

Secondary

  • The progression-free survival (PFS)
  • The overall survival(OS).
  • 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.

Patients are seen in follow-up every 3 months for 2 years and then every 6 months thereafter. Physical examination and CT scans of the thorax and upper abdomen are performed routinely.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
Study Start Date : May 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Endostatin combine CCRT
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
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




Primary Outcome Measures :
  1. Response Rate (RR) [ Time Frame: 4 weeks after CCRT ]
    Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 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.

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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218594


Locations
China, Guangdong
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
The Affiliated Hospital of Guangdong Medical College
Fujian Province Tumor Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangxi Medical University
Zhejiang Cancer Hospital
Guangzhou General Hospital of Guangzhou Military Command
The 458 Hospital of Chinese PLA
Investigators
Study Chair: Ming Chen, Doctor Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ming Chen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01218594     History of Changes
Other Study ID Numbers: DP-EN-RT
First Posted: October 11, 2010    Key Record Dates
Results First Posted: October 17, 2012
Last Update Posted: October 17, 2012
Last Verified: August 2012

Keywords provided by Ming Chen, Sun Yat-sen University:
Stage III
Unresectable
Non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endostatins
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors