Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01291823

Enrollment

Registered

2011-02-08

Start date

2010-12-31

Completion date

2014-12-31

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

gefitinib, radiation, esophageal cancer

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.

Interventions

DRUGgefitinib

gefitinib 250mg/day

RADIATIONThoracic radiotherapy

Thoracic radiotherapy 54-60Gy over 30 fraction

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Tumor response rate	1 month after the thoracic radiotherapy and concurrent gefitinib treatment

Secondary

Measure	Time frame
The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)	1 month after treatment

Countries

China

Contacts

Primary ContactMao Weimin, MD

maowmzj1218@163.com0086-571-88122222

Backup ContactXu Yaping, MD

xuyaping1207@gmail.com0086-571-88122082

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026