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Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gefitinib
Thoracic radiotherapy
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring gefitinib, radiation, esophageal cancer

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically documented diagnosis of esophageal Cancer
  • Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible
  • age:70-85 years
  • Written informed consent.
  • Performance status of 0 to 2
  • Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L.
  • Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement
  • Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)

Exclusion Criteria:

  • Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • Prior systemic chemotherapy or radiation therapy for esophageal cancer

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concomitant Gefitinib and radiotherapy

Arm Description

Patients received Gefitinib and radiation therapy

Outcomes

Primary Outcome Measures

Tumor response rate

Secondary Outcome Measures

The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)

Full Information

First Posted
February 4, 2011
Last Updated
February 7, 2011
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01291823
Brief Title
Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer
Official Title
A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.
Detailed Description
Purpose: to evaluate the efficacy and toxicity of a concomitant treatment using EGFR-TKI and thoracic radiation in elderly patients with esophageal Cancer. Methods:Patients(>70 years old) with esophageal Cancer will receive thoracic radiation therapy 54-60 Gy over 30 fractions and concurrent with gefitinib 250mg/day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
gefitinib, radiation, 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
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concomitant Gefitinib and radiotherapy
Arm Type
Experimental
Arm Description
Patients received Gefitinib and radiation therapy
Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Description
gefitinib 250mg/day
Intervention Type
Radiation
Intervention Name(s)
Thoracic radiotherapy
Intervention Description
Thoracic radiotherapy 54-60Gy over 30 fraction
Primary Outcome Measure Information:
Title
Tumor response rate
Time Frame
1 month after the thoracic radiotherapy and concurrent gefitinib treatment
Secondary Outcome Measure Information:
Title
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)
Time Frame
1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically documented diagnosis of esophageal Cancer Disease must be encompassed in a radiotherapy field.Patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible age:70-85 years Written informed consent. Performance status of 0 to 2 Neutrophil count >1.5 x 10 to the 9th power/L and platelets > 100 x 10 to the 9th power/L. Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN) Exclusion Criteria: Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). Prior systemic chemotherapy or radiation therapy for esophageal cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mao Weimin, MD
Phone
0086-571-88122222
Email
maowmzj1218@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Yaping, MD
Phone
0086-571-88122082
Email
xuyaping1207@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mao Weimin, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xu yaping, MD
Organizational Affiliation
0086-571-88122082
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu yaping, MD
Phone
0086-571-88122
Email
xuyaping1207@gmail.com

12. IPD Sharing Statement

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Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

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