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

Peking University92 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

SCCHN

Interventions

Eligibility

Sex: ALLMin age: 65 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective response rate: complete response + partial response on RECIST evaluation system

Time frame: 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

Time frame: participants will be followed during the treatment,an expected average of 6 weeks

Objective response rate: complete response + partial response on RECIST

Time frame: 3-months after treatment

Secondary Outcomes

Evaluate the Local control Rate in 2 years.

Time frame: 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.

Time frame: participants will be followed during the treatment,an expected average of 6 weeks

Evaluate the overall survival of the patient in 2 years.

Time frame: up to 2 years

Evaluate the progression free survival of the patient in 2 years.

Time frame: 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.

Time frame: every 3 months after treatment

Evaluate the Local control Rate in 3 years.

Time frame: up to 3 years

Evaluate the Local control Rate in 5 years.

Time frame: up to 5 years

Evaluate the overall survival of the patient in 3 years.

Time frame: up to 3 years

Evaluate the overall survival of the patient in 5 years.

Time frame: up to 5 years

Evaluate the progression free survival of the patient in 3 years.

Time frame: up to 3 years

Evaluate the progression free survival of the patient in 5 years.

Time frame: up to 5 years