Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Nimotuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 70 years or older; treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT; stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system; estimated survival time ≥3 months; Karnofsky performance score ≥70; adequate bone marrow, as well as hepatic and renal function; voluntary written consent provided prior to treatment. Exclusion Criteria: esophagobronchial or esophagomediastinal fistula; patients who had joined other clinical trials prior to this treatment; serious heart, liver, and/or kidney insufficiency; serious infectious disease; relapse disease or distant metastasis; recently diagnosed neoplastic diseases; previous receipt of surgery, chemotherapy, or radiotherapy for EC.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: radiotherapy<br>It is just a single group assignment | Drug: Nimotuzumab<br>* Nimotuzumab 200mg,once per week,for 5 to 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Nimotuzumab combined with Radiotherapy for older patients | To observe the adverse events during the treatment | 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, targeted therapy, esophageal cancer, older