Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial|
- Safety of Nimotuzumab combined with Radiotherapy for older patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To observe the adverse events during the treatment
- Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]To observe the response rate, progress-free survival and overall survival
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
It is just a single group assignment
Nimotuzumab 200mg,once per week,for 5 to 6 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463605
|Cancer Hospital, Chinese Academy of Medical Sciences|
|Beijing, Beijing, China, 100021|
|Principal Investigator:||Liang Jun, Doctor||Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences|