Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd.
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: | 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:
Further study details as provided by Jiangsu Simcere Pharmaceutical 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
No publications provided
| 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 |
| Health Authority: | China:SFDA |
Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
|
Endostar Radiotherapy Esophageal Cancer |
Additional relevant MeSH terms:
|
Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases |
Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on March 03, 2015