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Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

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ClinicalTrials.gov Identifier: NCT01368419
Recruitment Status : Unknown
Verified April 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 8, 2011
Last Update Posted : April 24, 2013
Sponsor:
Collaborator:
The First People's Hospital of Lianyungang
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief Summary:
This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Endostar Radiation: Radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
Study Start Date : May 2011
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment Drug: Endostar
75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks
Radiation: Radiotherapy
6~15MV X-ray, 2Gy/time,5times/week,6 weeks



Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 1 month after treatment ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 years ]
  2. Time to Progression (TTP) [ Time Frame: every three months until disease progression ]
  3. Clinical Benefit Rate (CBR) [ Time Frame: 1 month after treatment ]
  4. Serum VEGF Levels [ Time Frame: at baseline and 6 weeks ]
  5. Incidence of Adverse Events [ Time Frame: up to 3 months ]


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

Inclusion Criteria:

  • Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer
  • Measurable disease according to RECIST criteria
  • ECOG Performance Status 0-1
  • The length of esophageal carcinoma ≤ 10 cm
  • Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
  • Renal function: Cr ≤ 2.0×UNL
  • Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL

Exclusion Criteria:

  • Pregnant or lactating women
  • Evidence of bleeding diathesis, serious infection
  • Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
  • Uncontrollable mental and nervous disorders

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): NCT01368419


Contacts
Contact: Xiaodong Jiang, MD 86-0518-85605120

Locations
China, Jiangsu
The First People's Hospital of Lianyungang Recruiting
Lianyungang, Jiangsu, China, 222002
Contact: Xiaodong Jiang, MD    0518-85605120      
Principal Investigator: Xiaodong Jiang, MD         
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
The First People's Hospital of Lianyungang
Investigators
Principal Investigator: Xiaodong Jiang, MD The First People's Hospital of Lianyungang

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01368419     History of Changes
Other Study ID Numbers: Endu-201105
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Endostar
Radiotherapy
Esophageal Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases