This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer. All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration. Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.
Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy
Patients received daily RT to the chest
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
overall survival
Time frame: 3 years
Objective Response Rate
Time frame: 3 years
progression-free survival
Time frame: 3 years
rate of grade 3-4 radiation esophagitis
rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0
Time frame: 1 years
rate of grade 3-4 radiation pneumonitis
rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0
Time frame: 1 year
Failure patterns
rates of local-regional recurrence, distant metastasis and brain metastasis
Time frame: 3 years
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