- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368419
Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
April 22, 2013 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaodong Jiang, MD
- Phone Number: 86-0518-85605120
Study Locations
-
-
Jiangsu
-
Lianyungang, Jiangsu, China, 222002
- Recruiting
- The First People's Hospital of Lianyungang
-
Contact:
- Xiaodong Jiang, MD
- Phone Number: 0518-85605120
-
Principal Investigator:
- Xiaodong Jiang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks
6~15MV X-ray, 2Gy/time,5times/week,6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate (ORR)
Time Frame: 1 month after treatment
|
1 month after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival (OS)
Time Frame: 2 years
|
2 years
|
Time to Progression (TTP)
Time Frame: every three months until disease progression
|
every three months until disease progression
|
Clinical Benefit Rate (CBR)
Time Frame: 1 month after treatment
|
1 month after treatment
|
Serum VEGF Levels
Time Frame: at baseline and 6 weeks
|
at baseline and 6 weeks
|
Incidence of Adverse Events
Time Frame: up to 3 months
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Xiaodong Jiang, MD, The First People's Hospital of Lianyungang
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Anticipated)
May 1, 2013
Study Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
June 6, 2011
First Posted (Estimate)
June 8, 2011
Study Record Updates
Last Update Posted (Estimate)
April 24, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Endostar protein
Other Study ID Numbers
- Endu-201105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Cancer
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
-
National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedEsophageal Cancer | Gastrooesophageal Cancer | Oesophageal Cancer | GastroEsophageal Cancer | Esophageal Cancers NOS | Oesophageal Cancer Metastatic | Esophageal Cancer Metastatic | Oesophageal Cancer NosGermany
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University of Wisconsin, MadisonActive, not recruitingResectable Esophageal Cancer | GastroEsophageal CancerUnited States
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Tianjin Medical University Cancer Institute and...Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsNot yet recruitingStage III Esophageal Cancer | Stage II Esophageal Cancer
-
Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
-
Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
-
Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7 | Malignant Neoplasm of the Cervical Esophagus | Malignant Neoplasm...United States
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-
Fudan UniversityUnknown
-
Affiliated Hospital of North Sichuan Medical CollegeJiangsu Simcere Pharmaceutical Co., Ltd.Unknown
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Dong WangUnknownNon-squamous Non-small Cell Lung CancerChina
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Simcere Pharmaceutical Co., LtdThe Affiliated Changzhou Tumor Hospital of Suzhou UniversityUnknownColorectal NeoplasmsChina
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Fujian Cancer HospitalUnknownBreast Cancer | Angiogenesis
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Shandong Simcere-Medgenn Bio-pharmaceutical Co....Unknown
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