Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.
|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|