Safety and Efficacy Study of Target Therapy Combined With Radiotherapy to Treat Senile Locally Advanced SCCHN

Study Overview
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Brief Summary
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Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence indicates combination with EGFR Target therapy can bring benefit for the patients. Senile Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of the study Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN was sponsored to evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN patients.

Detailed Description
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condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A: Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2

Official Title
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Prospective, Randomized, Controlled, Phase II，Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN

Conditions
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SCCHN

Intervention / Treatment
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* Drug: Nimotuzumab and Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form Age 65-85，both genders HNSCC Confirmed by pathology Primary site of oral cavity, oropharynx, hypopharynx, larynx Stage Ⅲ/ⅣA,B Primary lesions can be measured Karnofsky's Performance Scale ≥60 Life expectancy of more than 6 months Haemoglobin≥100g/L ,WBC ≥3.5×109/L, platelet count≥90×109/L Hepatic function: ALT、AST< 1.5 x ULN, TBIL< 1.5 x ULN Renal function: Creatinine < 1.5 x ULN Exclusion Criteria: Received other anti EGFR monoclonal antibody treatment Previous chemotherapy or radiotherapy Participation in other interventional clinical trials within 1 month Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix) History of serious allergic or allergy History of Serious lung or heart disease

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy + Nimotuzumab<br>Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F Nimotuzumab (Nimo) weekly Nimo (200 mg) × 8, started 1 w before RT | Drug: Nimotuzumab and Radiotherapy<br>* Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT<br>* Other names: Nimotuzumab combined with radiotherapy;|
| Active Comparator: Radiotherapy (RT)<br>Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F | Drug: Nimotuzumab and Radiotherapy<br>* Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT<br>* Other names: Nimotuzumab combined with radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate: complete response + partial response on RECIST evaluation system |  | 1-month after treatment | 
| Evaluate the Safety of Nimotuzumab Combined with Radiotherapy for old patients. Record the Number and Grade of Participants with Adverse Events as a Measure of Safety and Tolerability |  | participants will be followed during the treatment,an expected average of 6 weeks | 
| Objective response rate: complete response + partial response on RECIST |  | 3-months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Local control Rate in 2 years. |  | up to 2 years | 
| Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone. | Record the subjective description of the patients by themself according to the QOL table. | participants will be followed during the treatment,an expected average of 6 weeks | 
| Evaluate the overall survival of the patient in 2 years. |  | up to 2 years | 
| Evaluate the progression free survival of the patient in 2 years. |  | up to 2 years | 
| Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone. | Record the subjective description of the patients by themself according to the QOL table. | every 3 months after treatment | 
| Evaluate the Local control Rate in 3 years. |  | up to 3 years | 
| Evaluate the Local control Rate in 5 years. |  | up to 5 years | 
| Evaluate the overall survival of the patient in 3 years. |  | up to 3 years | 
| Evaluate the overall survival of the patient in 5 years. |  | up to 5 years | 
| Evaluate the progression free survival of the patient in 3 years. |  | up to 3 years | 
| Evaluate the progression free survival of the patient in 5 years. |  | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Target therapy