Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01291823
• Other study ID #: ZhejiangCH10
• 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

• Esophageal Cancer
• Esophageal Neoplasms

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