- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375581
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Bing Xia, MD
- Phone Number: 86 571 64006039
- Email: bxia_hzch@hotmail.com
Study Locations
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
125mg, Po, TID during RT
Other Names:
involved-Field irradiaton without elective nodal irradiation
|
Active Comparator: Radiotherapy alone
Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT.
|
involved-Field irradiaton without elective nodal irradiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence rates of radiation-related pneumonitis and esophagitis
Time Frame: within the 3 months after the initiation of RT
|
within the 3 months after the initiation of RT
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shixiu Wu, MD, Hangzhou Cancer Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HZFH CA15-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
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Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
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Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
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Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
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