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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
Sponsor:
Information provided by:
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01291823
First received: February 4, 2011
Last updated: February 7, 2011
Last verified: February 2011
  Purpose
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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   70 Years to 85 Years   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291823

Locations
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01291823     History of Changes
Other Study ID Numbers: ZhejiangCH10 
Study First Received: February 4, 2011
Last Updated: February 7, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Zhejiang Cancer Hospital:
gefitinib
radiation
esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016