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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375581
• Other study ID #: HZFH CA15-01
• Status: Recruiting
• Phase: Phase 2
• First received: February 16, 2015
• Last updated: March 6, 2015
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2015
• Source: First People's Hospital of Hangzhou
• Contact: Bing Xia, MD
• Phone: 86 571 64006039
• Email: bxia_hzch[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Icotinib
125mg, Po, TID during RT

Radiation:
• Thoracic radiotherapy
involved-Field irradiaton without elective nodal irradiation

Locations

Country	Name	City	State
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		2 years	No
Secondary	incidence rates of radiation-related pneumonitis and esophagitis		within the 3 months after the initiation of RT	Yes