Clinical trial NCT01393184: Safety and Efficacy Study of Target Therapy Combined With Radiotherapy to Treat Senile Locally Advanced SCCHN
Official title: Prospective, Randomized, Controlled, Phase II，Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: SCCHN
Keywords: Target therapy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Biotech Pharmaceutical Co., Ltd.
First posted: 2011-07-13
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Objective response rate: complete response + partial response on RECIST evaluation system
timeFrame: 1-month after treatment
measure: 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
timeFrame: participants will be followed during the treatment,an expected average of 6 weeks
measure: Objective response rate: complete response + partial response on RECIST
timeFrame: 3-months after treatment
Secondary outcomes:
measure: Evaluate the Local control Rate in 2 years.
timeFrame: up to 2 years
measure: Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.
timeFrame: participants will be followed during the treatment,an expected average of 6 weeks
measure: Evaluate the overall survival of the patient in 2 years.
timeFrame: up to 2 years
measure: Evaluate the progression free survival of the patient in 2 years.
timeFrame: up to 2 years
measure: Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.
timeFrame: every 3 months after treatment
measure: Evaluate the Local control Rate in 3 years.
timeFrame: up to 3 years
measure: Evaluate the Local control Rate in 5 years.
timeFrame: up to 5 years
measure: Evaluate the overall survival of the patient in 3 years.
timeFrame: up to 3 years
measure: Evaluate the overall survival of the patient in 5 years.
timeFrame: up to 5 years
measure: Evaluate the progression free survival of the patient in 3 years.
timeFrame: up to 3 years
measure: Evaluate the progression free survival of the patient in 5 years.
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University, School of Oncology, Beijing Cancer Hospital & Institute
name: Sun Yan, MD
role: PRINCIPAL_INVESTIGATOR
References: