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Trial Title:
Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer
NCT ID:
NCT01291823
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Gefitinib
Conditions: Keywords:
gefitinib
radiation
esophageal cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
gefitinib
Description:
gefitinib 250mg/day
Arm group label:
Concomitant Gefitinib and radiotherapy
Intervention type:
Radiation
Intervention name:
Thoracic radiotherapy
Description:
Thoracic radiotherapy 54-60Gy over 30 fraction
Arm group label:
Concomitant Gefitinib and radiotherapy
Summary:
Elderly patients with esophageal cancer will receive thoracic radiation therapy 54-60Gy
over 30 fractions, and concurrent with Gefitinib.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
70 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu yaping, MD
Phone:
0086-571-88122
Email:
xuyaping1207@gmail.com
Start date:
December 2010
Completion date:
December 2014
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01291823
