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

Sponsor
First People's Hospital of Hangzhou (Other)
Overall Status
Unknown status
CT.gov ID
NCT02375581
Collaborator
(none)
130
Enrollment
1
Location
2
Arms
47
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. all cause mortality [2 years]

    Secondary Outcome Measures

    1. incidence rates of radiation-related pneumonitis and esophagitis [within the 3 months after the initiation of RT]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 109/L; ANC ≥ 1.5x 109/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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hangzhou Cancer Hospital Hangzhou Zhejiang China 310002

    Sponsors and Collaborators

    • First People's Hospital of Hangzhou

    Investigators

    • Principal Investigator: Shixiu Wu, MD, Hangzhou Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First People's Hospital of Hangzhou
    ClinicalTrials.gov Identifier:
    NCT02375581
    Other Study ID Numbers:
    • HZFH CA15-01
    First Posted:
    Mar 2, 2015
    Last Update Posted:
    Mar 22, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by First People's Hospital of Hangzhou
    Radiotherapy
    Icotinib
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Mar 22, 2016