Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

NCT05735145RecruitingPHASE3INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Enrollment

108

Start Date

2022-07-01

Completion Date

2025-06-30

Study Type

INTERVENTIONAL

Official Title

A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging

Interventions

paclitaxel combined with platinum

Conditions

Uterine Cervical NeoplasmsChemoradiotherapyAdjuvant Chemotherapy

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* Cervical cancer confirmed by histopathology incloud squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma
* FIGO stage IB3, IIA2, IIB-IVA patients in 2018
* Locally advanced cervical cancer patients received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment after diagnosis, and the effect reached CR after treatment
* Aged 18-75 years
* PS score 0-1
* Serum 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 UNL
* Sign 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 treatment
* Patients who have received neoadjuvant chemotherapy and surgery
* Patients with cognitive impairment
* Patients with any distant metastases
* Patients with any other malignancy within 5 years
* Any 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 contraception
* Severe bone marrow dysfunction
* Patients with bleeding tendency
* Drug abusers or alcohol addicts
* Those who are known to have a third or fourth degree allergic reaction to any treatment in the study

Outcome Measures

Primary Outcomes

PFS

progression-free survival

Time frame: Refers to the time from randomization to the first occurrence of disease progression or death from any cause,whichever came first, assessed up to 1000 months

Secondary Outcomes

OS

Overall survival

Time frame: Refers to the time from randomization to death from any cause, assessed up to 1000 months

Locations

the Fourth Affiliated Hospital of Guangxi Medical University, Liuchow, China

Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer