NCT01368419

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

June 1, 2011

Last Update Submit

April 22, 2013

Conditions

Esophageal Cancer

Keywords

EndostarRadiotherapyEsophageal Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    1 month after treatment

Secondary Outcomes (5)

  • Overall Survival (OS)

    2 years

  • Time to Progression (TTP)

    every three months until disease progression

  • Clinical Benefit Rate (CBR)

    1 month after treatment

  • Serum VEGF Levels

    at baseline and 6 weeks

  • Incidence of Adverse Events

    up to 3 months

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: EndostarRadiation: Radiotherapy

Interventions

EndostarDRUG

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

Treatment
RadiotherapyRADIATION

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

Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222002, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

endostar proteinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Xiaodong Jiang, MD

    The First People's Hospital of Lianyungang

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Jiang, MD

CONTACT

86-0518-85605120

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 8, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

CN(1)