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

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

Thoracic radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Radiotherapy, Icotinib

Eligibility Criteria

70 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed esophageal carcinoma
Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy
Aged ≥ 70 and < 85 years, behavioral status evaluation ECOG scores 0-2
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
Subjects should sign for the informed consent
Subjects should perform good compliance

Exclusion Criteria:

Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
Complete obstruction of the esophagus, or patients who have the potential to develop perforation
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
Patients who have multiple foci esophageal carcinomas
Patients who are/were given any other medicine tests currently/in last 4 weeks
Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
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.

Sites / Locations

Hangzhou Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Icotinib & Radiotherapy

Radiotherapy alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

incidence rates of radiation-related pneumonitis and esophagitis

Full Information

NCT ID

NCT02375581

First Posted

February 16, 2015

Last Updated

March 18, 2016

Sponsor

First People's Hospital of Hangzhou

1. Study Identification

Unique Protocol Identification Number

NCT02375581

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First People's Hospital of Hangzhou

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

Radiotherapy, Icotinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Icotinib & Radiotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

Radiotherapy alone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Icotinib

Other Intervention Name(s)

Conmana

Intervention Description

125mg, Po, TID during RT

Intervention Type

Radiation

Intervention Name(s)

Thoracic radiotherapy

Intervention Description

involved-Field irradiaton without elective nodal irradiation

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

2 years

Secondary Outcome Measure Information:

Title

incidence rates of radiation-related pneumonitis and esophagitis

Time Frame

within the 3 months after the initiation of RT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed esophageal carcinoma Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy Aged ≥ 70 and < 85 years, behavioral status evaluation ECOG scores 0-2 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 Subjects should sign for the informed consent Subjects should perform good compliance Exclusion Criteria: Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy Complete obstruction of the esophagus, or patients who have the potential to develop perforation 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 Patients who have multiple foci esophageal carcinomas Patients who are/were given any other medicine tests currently/in last 4 weeks Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bing Xia, MD

Phone

86 571 64006039

bxia_hzch@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shixiu Wu, MD

Organizational Affiliation

Hangzhou Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hangzhou Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bing Xia, MD

Phone

86 571 56006388

bxia_hzch@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

33026449

Citation

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.

Results Reference

derived

Learn more about this trial

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

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