Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer
NCT ID: NCT01291823
Last Updated: 2011-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2010-12-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Concomitant Gefitinib and radiotherapy
Patients received Gefitinib and radiation therapy
gefitinib
gefitinib 250mg/day
Thoracic radiotherapy
Thoracic radiotherapy 54-60Gy over 30 fraction
Interventions
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gefitinib
gefitinib 250mg/day
Thoracic radiotherapy
Thoracic radiotherapy 54-60Gy over 30 fraction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
85 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
Responsible Party
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Zhejiang Cancer Hospital
Principal Investigators
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Mao Weimin, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Xu yaping, MD
Role: PRINCIPAL_INVESTIGATOR
0086-571-88122082
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZhejiangCH10
Identifier Type: -
Identifier Source: org_study_id
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