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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

NCT02716688

Esophageal Cancer S-1 Radiotherapy

WITHDRAWN PHASE2

Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer

NCT07015489

ESCC

COMPLETED PHASE2

Gefitinib Combined With Radiotherapy in Elderly Patients With Esophageal Cancer

NCT01291823

Esophageal Cancer

UNKNOWN PHASE2

Raltitrexed Concurrent With Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus

NCT03585530

Esophagus Squamous Cell Carcinoma

UNKNOWN PHASE2

High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

NCT03535207

Esophageal Cancer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Icotinib & Radiotherapy

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

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

125mg, Po, TID during RT

Thoracic radiotherapy

Intervention Type RADIATION

involved-Field irradiaton without elective nodal irradiation

Radiotherapy alone

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

Group Type ACTIVE_COMPARATOR

Thoracic radiotherapy

Intervention Type RADIATION

involved-Field irradiaton without elective nodal irradiation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Icotinib

125mg, Po, TID during RT

Intervention Type DRUG

Thoracic radiotherapy

involved-Field irradiaton without elective nodal irradiation

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Conmana

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

70 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No