Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
This trial is active, not recruiting.
|Sponsor||Chinese Academy of Medical Sciences|
|Start date||October 2011|
|End date||August 2014|
|Trial size||30 participants|
|Trial identifier||NCT01463605, 11-49/484|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
It is just a single group assignment
Safety of Nimotuzumab combined with Radiotherapy for older patients
time frame: 2 years
Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients
time frame: 3 years
Male or female participants at least 70 years old.
- ≥ 70 year-old
- Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only)
- No previous surgery, radiotherapy or chemotherapy of cancer was allowed
- Estimated survival time ≥ 3 months
- KPS > 60
- No serious diseases of important organs
- Signed consent forms voluntarily
- History of other malignant disease which has not been cured
- Joining other clinical trial prior this study.
|Official title||Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial|
|Principal investigator||Liang Jun, Doctor|
|Description||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.|
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