To observe the efficacy and safety of hydrochloride anlotinib combined with concurrent radiochemotherapy for patients with FIGO stage IB3 and IIA2-IVA cervical cancer. Patient characteristics, image and genetic information of tumor, microbial sample of tumor microenvironment and biomarker in the blood sample will be collected and analysis by multi-omics and bioinformatic technology. Aim to provide a new treatment module for cervical cancer.
Patients diagnosed pathologically as cervical cancer (squamous carcinoma, adenocarcinoma or adenosquamous carcinoma) with stage of FIGO IB3 and IIA2 to IVB will be included in this study according to the prescribed criteria in the protocal. Classical radiochemotherapy will be conducted by clinical routine method. Radiation will be given by external beam radiation of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks. Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime and for patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug. Apart from that, hydrochloride anlotinib, a multiple targets anti-angiogenesis kinase approved by CFDA, will be orally taken daily at a dose of 12mg for 14 days aiming to improve tumor response. Then rest for 7 days and start a new cycles for a total of 3 cycles. First capsule of anlotinib will be taken 7 days before the first radiation. Once the treatment is finished, patients will be examination for tumor evaluation and toxicity monitor every 3 months for the first 2 years and then every half years for the third year unless progression or death. During those period, patient characteristics, image data, tumor tissue, blood, urine, stool and microbial sample of tumor micro environment will be collected and analysis by multi-omics and bioinformatic technology. A total of 53 patients will be included and this study will be conducted in the department of radiation and clinical oncology in Zhongnan Hospital of Wuhan University.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
Hydrochloride anlotinib is a small molecular anti-angiogenesis drug with multiple targets. It will be taken at a starting dose of 12 mg for 14 days. Then participants will rest for 7 days and start a new cycles. At most of 3 cycles will be administrated. If intolerable toxicity happen, dosage of 10mg or 8mg will be taken.
Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime. For patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug.
Radiation will be given by external beam of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITING3 years disease free survival rate
Proportion of participants without tumor recurrence or death at 3 years from enrollment
Time frame: 3 years from enrollment
Adverse events
Adverse events data according to CTCAE version 5.0
Time frame: From enrollment to 90 days after treatment finish
3 years overall survival rate
Proportion of survival participants at 3 years from enrollment
Time frame: 3 years from enrollment
Objective response rate
Proportion of participants with complete response and partial response
Time frame: 5 years from enrollment
Disease control rate
Proportion of participants with complete response, partial response and stable disease
Time frame: 5 years from enrollment
5 years progression free survival rate
Proportion of participants without tumor progression or death at 3 years from enrollment
Time frame: 5 years from enrollment
5 years overall survival rate
Proportion of survival participants at 5 years from enrollment
Time frame: 5 years from enrollment
Median overall survival
Median survival time of all participants from enrollment to death of any reason
Time frame: 5 years of follow-up
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NONE
Enrollment
53
Median progression free survival
Median time of all participants from enrollment to tumor progression
Time frame: 5 years of follow-up
Score of life quality
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.
Time frame: 3 years from enrollment