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Recruiting NCT05735145

Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

Conditions: Uterine Cervical Neoplasms, Chemoradiotherapy, Adjuvant Chemotherapy

Sex: Female
Ages: 18 Years – 75 Years
Phase: PHASE3
Enrollment: 108
Sponsor: Fourth Affiliated Hospital of Guangxi Medical University

Location: China

Summary

This study carried out a prospective, randomized, controlled clinical study under the background of intensity-modulated radiation therapy and three-dimensional afterloading therapy. By comparing simultaneous intensity-modulated radiotherapy and chemotherapy combined with adjuvant chemotherapy and simultaneous intensity-modulated radiotherapy and chemotherapy alone, based on the 2018 FIGO staging The clinical efficacy of locally advanced cervical cancer further clarifies the role of adjuvant chemotherapy in locally advanced cervical cancer.

Eligibility Criteria

Inclusion Criteria:Cervical cancer confirmed by histopathology incloud squamous cell carcinoma, adenocarcinoma and adenosquamous carcinomaFIGO stage IB3, IIA2, IIB-IVA patients in 2018Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect reached CR after treatmentAged 18-75 yearsPS score 0-1Serum hemoglobin >=100*10^9/L, blood platelet >= 100000/μL, absolute count of neutrophils>=1500/μL; 7.Serum creatinine <=1.5 UNL or creatinine clearance >= 60 ml/min; 8.Serum bilirubin <=1.5 UNL, AST (SGOT) and ALT (SGPT)<= 1.5 UNLSign a formal informed consent to show that they understand that the study is in line with hospital and national policies .Estimated total survival > 6 months.Exclusion Criteria:Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect unreached CR after treatmentPatients who have received neoadjuvant chemotherapy and surgeryPatients with cognitive impairmentPatients with any distant metastasesPatients with any other malignancy within 5 yearsAny other disease or condition is contraindications to chemoradiotherapy (e.g., active infection, 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive therapy, etc.); 5.Pregnant or lactating women, or fertile women who do not use contraceptionSevere bone marrow dysfunctionPatients with bleeding tendencyDrug abusers or alcohol addictsThose who are known to have a third or fourth degree allergic reaction to any treatment in the study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05735145). StuddyBuddy aggregates publicly available trial information.