Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer

Recruiting now · Phase 3

Conditions studied: Uterine Cervical Neoplasms, Chemoradiotherapy, Adjuvant Chemotherapy

In brief

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.

Key facts

Study ID

NCT05735145

Run by

Fourth Affiliated Hospital of Guangxi Medical University

People needed

108

Starts

2022-07-01

Expected to finish

2027-06-30

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• the Fourth Affiliated Hospital of Guangxi Medical University — Liuzhou, Guangxi, China (enrolling)

Full record on ClinicalTrials.gov

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