Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Radiation: Thoracic radiotherapy; Drug: gefitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT01291823

ZhejiangCH10

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

70 participants in 1 patient group

Concomitant Gefitinib and radiotherapy

Experimental group

Description:

Patients received Gefitinib and radiation therapy

Treatment:

Drug: gefitinib

Radiation: Thoracic radiotherapy