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

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

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

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Icotinib; Radiation: Thoracic radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310002
      • Recruiting
      • Hangzhou Cancer Hospital
      • Contact: Bing Xia, MD; Phone Number: 86 571 56006388; Email: bxia_hzch@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib & Radiotherapy; Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT.	Drug: Icotinib; 125mg, Po, TID during RT; Other Names: Conmana; Radiation: Thoracic radiotherapy; involved-Field irradiaton without elective nodal irradiation
Active Comparator: Radiotherapy alone; Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT.	Radiation: Thoracic radiotherapy; involved-Field irradiaton without elective nodal irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence rates of radiation-related pneumonitis and esophagitis	within the 3 months after the initiation of RT

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Investigators: Principal Investigator: Shixiu Wu, MD, Hangzhou Cancer Hospital

Publications and helpful links

General Publications

• Luo H, Jiang W, Ma L, Chen P, Fang M, Ding L, Hua Y, Du D, Jing Z, Xie R, Song Y, Wang J, Zhou R, Tian Z, Wu S. Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019440. doi: 10.1001/jamanetworkopen.2020.19440.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 18, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Radiotherapy; Icotinib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: HZFH CA15-01