Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Radiation: Thoracic radiotherapy; Drug: Icotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02375581

HZFH CA15-01

Details and patient eligibility

About

To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 70 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Icotinib & Radiotherapy

Experimental group

Description:

Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT.

Treatment:

Drug: Icotinib

Radiation: Thoracic radiotherapy

Radiotherapy alone

Active Comparator group

Description:

Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT.

Treatment:

Radiation: Thoracic radiotherapy