To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma
This is a perspective, multi-center, open-label and single arm study.
Study Type
OBSERVATIONAL
Enrollment
125
Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.
IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8\~2.0Gy/f, 25\~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60\~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy. Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80\~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks.
Peking University 3rd Hospital
Beijing, Beijing Municipality, China
3-year disease-free survival(DFS)
The rate of patient without disease in 3 years after treatment
Time frame: up to 3 years
Complete response rate(CRR)
The percentage of subjects who achieve complete response by imaging assessment from the end of the treatment to disease progression
Time frame: 3 months later after treatment
Objective response rate(ORR)
The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment
Time frame: 3 months later treatment
3-year overall survival(OS)
The rate of patient alive in 3 years after treatment
Time frame: up to 3 years
The change of tumor related markers
the correlation of the value of SCC,Cyfra 21-1 and therapeutic effect \[The changes of serum tumor markers (such as SCC-Ag and CYFRA21-1) were observed before and after treatment\]
Time frame: up to 3 years
The change of cervical tumor
the change of the volume of the cervical tumor at diagnosis and before brachytherapy
Time frame: At diagnosis and before brachytherapy
QUALITY OF LIFE(QoL)
Quality of life assessed by EORTC QLQ-CX 24 \[EORTC QLQ-CX 24 is a specific quality of life assessment scale based on EORTC QLQ-C 30, with 24 items\]
Time frame: up to 3 years
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SAFETY
Including severity of adverse events, the incidence of adverse events and serious adverse events. Adverse events should be reported and graded according to CTCAE version 5.0
Time frame: up to 3 years