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Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborator:
The First People's Hospital of Lianyungang
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01368419
First received: June 1, 2011
Last updated: April 22, 2013
Last verified: April 2013
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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: | 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 |
Resource links provided by NLM:
Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Primary Outcome Measures:
- Objective Response Rate (ORR) [ Time Frame: 1 month after treatment ]
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: 2 years ]
- Time to Progression (TTP) [ Time Frame: every three months until disease progression ]
- Clinical Benefit Rate (CBR) [ Time Frame: 1 month after treatment ]
- Serum VEGF Levels [ Time Frame: at baseline and 6 weeks ]
- Incidence of Adverse Events [ Time Frame: up to 3 months ]
| 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 (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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01368419
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 Co., Ltd.
The First People's Hospital of Lianyungang
Investigators
| Principal Investigator: | Xiaodong Jiang, MD | The First People's Hospital of Lianyungang |
More Information
| Responsible Party: | Jiangsu Simcere Pharmaceutical 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 |
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 |
ClinicalTrials.gov processed this record on August 17, 2017