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Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT01291823
Recruitment Status : Unknown
Verified February 2011 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : February 8, 2011
Last Update Posted : February 8, 2011
Information provided by:
Zhejiang Cancer Hospital

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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: gefitinib Radiation: Thoracic radiotherapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Study Start Date : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291823

Contact: Mao Weimin, MD 0086-571-88122222 maowmzj1218@163.com
Contact: Xu Yaping, MD 0086-571-88122082 xuyaping1207@gmail.com

China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xu yaping, MD    0086-571-88122    xuyaping1207@gmail.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Principal Investigator: Mao Weimin, MD Zhejiang Cancer Hospital
Principal Investigator: Xu yaping, MD 0086-571-88122082

Responsible Party: MAO Weimin,XU Yaping, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01291823     History of Changes
Other Study ID Numbers: ZhejiangCH10
First Posted: February 8, 2011    Key Record Dates
Last Update Posted: February 8, 2011
Last Verified: February 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