SCCHN
Conditions
Keywords
Target therapy
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
Interventions
Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT
Sponsors
Biotech Pharmaceutical Co., Ltd.
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the progression free survival of the patient in 2 years. | up to 2 years | — |
| 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 Local control Rate in 2 years. | up to 2 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 | — |
| Evaluate the overall survival of the patient in 3 years. | up to 3 years | — |
| Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone. | participants will be followed during the treatment,an expected average of 6 weeks | 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 | — |
Outcome results
None listed