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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01291823
Other study ID # ZhejiangCH10
Secondary ID
Status Recruiting
Phase Phase 2
First received February 4, 2011
Last updated February 7, 2011
Start date December 2010
Est. completion date December 2014

Study information

Verified date February 2011
Source Zhejiang Cancer Hospital
Contact Mao Weimin, MD
Phone 0086-571-88122222
Email maowmzj1218@163.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date December 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 70 Years to 85 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
gefitinib
gefitinib 250mg/day
Radiation:
Thoracic radiotherapy
Thoracic radiotherapy 54-60Gy over 30 fraction

Locations

Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor response rate 1 month after the thoracic radiotherapy and concurrent gefitinib treatment Yes
Secondary The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) 1 month after treatment Yes
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