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

Peking University

Status and phase: Unknown; Phase 2

Conditions: SCCHN

Treatments: Drug: Nimotuzumab and Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01393184

BT-IST-SCCHN-040

Details and patient eligibility

About

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.

Full description

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

Enrollment: 92 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Radiotherapy + Nimotuzumab

Experimental group

Description:

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

Treatment:

Drug: Nimotuzumab and Radiotherapy

Radiotherapy (RT)

Active Comparator group

Description:

Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F

Treatment:

Drug: Nimotuzumab and Radiotherapy