The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.
This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
Zhujiang Hospital
Guangzhou, Guangdong, China
RECRUITINGprogress free survival rate
The rate of patient without progress disease in 3 years after treatment
Time frame: 3 years
Overall survival rate
The rate of patient alive in 3 years after treatment
Time frame: 3 years
Local area control rate.
The rate of patient without recurrence in 3 years after treatment
Time frame: 3 years
No distant metastatic survival.
The rate of patient without metastatic disease in 3 years after treatment
Time frame: 3 years
objective response rate
the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
Time frame: 3 years
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