Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
70 Years
N/A
Both
Esophageal Cancer
Trial Information
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
Study Design Primary Purpose: To evaluate the response rate, progression-free survival,
overall survival and complications.
Study Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number
of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30
patients
Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal
cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous
surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3
months, 5. KPS > 60, 6. No serious diseases of important organs, 7. Signed consent forms
voluntarily.
Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been
cured, 3. Joining other clinical trial prior this study.
Inclusion Criteria:
1. ≥ 70 year-old
2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node
metastasis only)
3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed
4. Estimated survival time ≥ 3 months
5. KPS > 60
6. No serious diseases of important organs
7. Signed consent forms voluntarily
Exclusion Criteria:
1. Psychopath
2. History of other malignant disease which has not been cured
3. Joining other clinical trial prior this study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety of Nimotuzumab combined with Radiotherapy for older patients
Outcome Description:
To observe the adverse events during the treatment
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Liang Jun, Doctor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
11-49/484
NCT ID:
NCT01463605
Start Date:
October 2011
Completion Date:
October 2014
Related Keywords:
- Esophageal Cancer
- radiotherapy
- targeted therapy
- esophageal cancer
- older
- Esophageal Diseases
- Esophageal Neoplasms
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