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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiotherapy | Other | It is just a single group assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab 200mg,once per week,for 5 to 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Nimotuzumab combined with Radiotherapy for older patients | To observe the adverse events during the treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients | To observe the response rate, progress-free survival and overall survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liang Jun, Doctor | Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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| Label | URL |
|---|---|
| This review discuss pre-clinical data and the rationale for targeting these pathways and summarize the results of clinical trials to-date. | View source |
| Changing healthcare practice of older adults with late-stage non-small cell lung cancer: practical considerations of targeted therapy in primary care and oncology. | View source |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |