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| Name | Class |
|---|---|
| Biotech Pharmaceutical Co., Ltd. | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy + Nimotuzumab | Experimental |
|
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| Radiotherapy (RT) | Active Comparator | Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab and Radiotherapy | Drug | Nimotuzumab (Nimo): Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Record the subjective description of the patients by themself according to the QOL table. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Yan, MD | Peking University, School of Oncology, Beijing Cancer Hospital & Institute | Principal Investigator |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| participants will be followed during the treatment,an expected average of 6 weeks |
| 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 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. | every 3 months after treatment |
| 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 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 |