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Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Endostar

Radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Endostar, Radiotherapy, Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The First People's Hospital of LianyungangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)

Secondary Outcome Measures

Overall Survival (OS)

Time to Progression (TTP)

Clinical Benefit Rate (CBR)

Serum VEGF Levels

Incidence of Adverse Events

Full Information

NCT ID

NCT01368419

First Posted

June 1, 2011

Last Updated

April 22, 2013

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

The First People's Hospital of Lianyungang

1. Study Identification

Unique Protocol Identification Number

NCT01368419

Brief Title

Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Official Title

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Collaborators

The First People's Hospital of Lianyungang

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

Endostar, Radiotherapy, Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Endostar

Intervention Description

75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

6～15MV X-ray, 2Gy/time，5times/week，6 weeks

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Time Frame

1 month after treatment

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Time Frame

2 years

Title

Time to Progression (TTP)

Time Frame

every three months until disease progression

Title

Clinical Benefit Rate (CBR)

Time Frame

1 month after treatment

Title

Serum VEGF Levels

Time Frame

at baseline and 6 weeks

Title

Incidence of Adverse Events

Time Frame

up to 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaodong Jiang, MD

Phone

86-0518-85605120

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaodong Jiang, MD

Organizational Affiliation

The First People's Hospital of Lianyungang

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First People's Hospital of Lianyungang

City

Lianyungang

State/Province

Jiangsu

ZIP/Postal Code

222002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaodong Jiang, MD

Phone

0518-85605120

First Name & Middle Initial & Last Name & Degree

Xiaodong Jiang, MD

12. IPD Sharing Statement

Learn more about this trial

Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

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