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Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
Information provided by:
Zhejiang Cancer Hospital Identifier:
First received: February 4, 2011
Last updated: February 7, 2011
Last verified: February 2011
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy over 30 fractions, and concurrent with Gefitinib.

Condition Intervention Phase
Esophageal Cancer Drug: gefitinib Radiation: Thoracic radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal

Resource links provided by NLM:

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • Tumor response rate [ Time Frame: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment ]

Secondary Outcome Measures:
  • The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.) [ Time Frame: 1 month after treatment ]

Estimated Enrollment: 70
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant Gefitinib and radiotherapy
Patients received Gefitinib and radiation therapy
Drug: gefitinib
gefitinib 250mg/day
Radiation: Thoracic radiotherapy
Thoracic radiotherapy 54-60Gy over 30 fraction

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.


Ages Eligible for Study:   70 Years to 85 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01291823

Contact: Mao Weimin, MD 0086-571-88122222
Contact: Xu Yaping, MD 0086-571-88122082

China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xu yaping, MD    0086-571-88122   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Principal Investigator: Mao Weimin, MD Zhejiang Cancer Hospital
Principal Investigator: Xu yaping, MD 0086-571-88122082
  More Information

Responsible Party: MAO Weimin,XU Yaping, Zhejiang Cancer Hospital Identifier: NCT01291823     History of Changes
Other Study ID Numbers: ZhejiangCH10
Study First Received: February 4, 2011
Last Updated: February 7, 2011

Keywords provided by Zhejiang Cancer Hospital:
esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017