Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

NCT ID: NCT01291823

Last Updated: 2011-02-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concomitant Gefitinib and radiotherapy

Patients received Gefitinib and radiation therapy

Group Type EXPERIMENTAL

gefitinib

Intervention Type DRUG

gefitinib 250mg/day

Thoracic radiotherapy

Intervention Type RADIATION

Thoracic radiotherapy 54-60Gy over 30 fraction

Interventions

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gefitinib

gefitinib 250mg/day

Intervention Type DRUG

Thoracic radiotherapy

Thoracic radiotherapy 54-60Gy over 30 fraction

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Mao Weimin, MD

Role: CONTACT

0086-571-88122222

Xu Yaping, MD

Role: CONTACT

0086-571-88122082

Facility Contacts

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Xu yaping, MD

Role: primary

0086-571-88122

Other Identifiers

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ZhejiangCH10

Identifier Type: -

Identifier Source: org_study_id

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