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Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

This study is currently recruiting participants.
Verified April 2013 by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Sponsor:
Collaborator:
The First People's Hospital of Lianyungang
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01368419
First received: June 1, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Esophageal Cancer
 Drug: Endostar
Radiation: Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to Progression (TTP) [ Time Frame: every three months until disease progression ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]
  • Serum VEGF Levels [ Time Frame: at baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: up to 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 R&D Co. Ltd.
The First People's Hospital of Lianyungang
Investigators
Principal Investigator: Xiaodong Jiang, MD The First People's Hospital of Lianyungang
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier: NCT01368419     History of Changes
Other Study ID Numbers: Endu-201105
Study First Received: June 1, 2011
Last Updated: April 22, 2013
Health Authority: China:SFDA

Keywords provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:
Endostar
Radiotherapy
Esophageal Cancer

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

ClinicalTrials.gov processed this record on May 16, 2013