The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.
For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc. In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGOverall survival rate
Described with Kaplan-Meier curves and unadjusted logrank tests.
Time frame: at 3 years
disease free survival rate
Time frame: at 3 years
non-distant metastasis survival rate
Time frame: at 3 years
survival period of non-progressive.
Time frame: at 3 years
Quality of life
Time frame: 3 years
Radiation protocol compliance
Time frame: 3 years
Rate of acute and long-term toxicities
Time frame: 3 years
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