NCT01291823UnknownPhase 2
A Phase II Study of Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Tumor response rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to 85 Years (Older Adult)
- Sex
- 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
Arms & Interventions
Concomitant Gefitinib and radiotherapy
Experimental
Patients received Gefitinib and radiation therapy
Intervention: gefitinib (Drug)
Concomitant Gefitinib and radiotherapy
Experimental
Patients received Gefitinib and radiation therapy
Intervention: Thoracic radiotherapy (Radiation)
Outcomes
Primary Outcomes
Tumor response rate
Time Frame: 1 month after the thoracic radiotherapy and concurrent gefitinib treatment
Secondary Outcomes
- The safety (The safety was evaluated according to the National Cancer Institute Common Toxicity Criteria version 3.0.)(1 month after treatment)
Investigators
Study Sites (1)
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