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

NCT ID: NCT01393184

Last Updated: 2011-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-03-31

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

Conditions

SCCHN

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy + Nimotuzumab

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

Group Type: EXPERIMENTAL

Nimotuzumab and Radiotherapy

Intervention Type: DRUG

Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT

Radiotherapy (RT)

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

Group Type: ACTIVE_COMPARATOR

Nimotuzumab and Radiotherapy

Intervention Type: DRUG

Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT

Interventions

Nimotuzumab and Radiotherapy

Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT

Intervention Type: DRUG

Other Intervention Names

Nimotuzumab combined with radiotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Peking University

Principal Investigators

Sun Yan, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Other Identifiers

BT-IST-SCCHN-040

Identifier Type: -

Identifier Source: org_study_id