An observational study in Cervical Squamous Cell Carcinoma, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-07-26.
Sponsored by Peking University Third Hospital · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 125 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The elder patients with cervical squamous cell cancer received nimotuzumab combined with radiotherapy.
No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:
Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L； Platelet count≥100×109/L； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；
Serum creatinine≤1.5×ULN or CrCl> 60 mL/min(according toCockcroft-Gault):
Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 / (72×Scr mg/dl)
Exclusion Criteria:
.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.
7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.
8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.
11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.
12)Other factors were assessed by investigators to be unsuitable to this study.
All patients will be treated with Nimotuzumab combined with radiotherapy.
Drug: Nimotuzumab · Radiation: EBRT combined with brachytherapy
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.
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
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
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital