Safety and Efficacy Study of Target Therapy Combined With Radiotherapy to Treat Senile Locally Advanced SCCHN
- Registration Number
- NCT01393184
- Lead Sponsor
- Peking University
- Brief Summary
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
condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A: Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 92
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiotherapy + Nimotuzumab Nimotuzumab and Radiotherapy 1. Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F 2. Nimotuzumab (Nimo) weekly Nimo (200 mg) × 8, started 1 w before RT Radiotherapy (RT) Nimotuzumab and Radiotherapy Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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. every 3 months after treatment Record the subjective description of the patients by themself according to the QOL table.
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 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