Esophageal Cancer
Conditions
Keywords
Radiotherapy, Icotinib
Brief summary
To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.
Detailed description
Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including surgery or concurrent chemoradiotherapy. EGFR is overexposed in most of the cases. In this phase II trial, the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy will be investigated in this setting.
Interventions
DRUGIcotinib
125mg, Po, TID during RT
RADIATIONThoracic radiotherapy
involved-Field irradiaton without elective nodal irradiation
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically confirmed esophageal carcinoma 2. Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy 3. Aged ≥ 70 and \< 85 years, behavioral status evaluation ECOG scores 0-2 4. In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 80 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN 5. Subjects should sign for the informed consent 6. Subjects should perform good compliance
Exclusion criteria
1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy 2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years 4. Patients who have multiple foci esophageal carcinomas 5. Patients who are/were given any other medicine tests currently/in last 4 weeks 6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines 7. Patients who have complications as following: (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| incidence rates of radiation-related pneumonitis and esophagitis | within the 3 months after the initiation of RT |
Countries
China
Contacts
Primary ContactBing Xia, MD
Outcome results
None listed