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A prospective randomized controlled trial for concurrent chemoradiotherapy combined with adjuvant chemotherapy in the treatment of advanced cervical cancer at 2018 FIGO staging

A prospective randomized controlled trial for concurrent chemoradiotherapy combined with adjuvant chemotherapy in the treatment of advanced cervical cancer at 2018 FIGO staging

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040938
Enrollment
Unknown
Registered
2020-12-16
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

Group 2:concurrent chemoradiotherapy combined with adjuvant chemotherapy
Group 1:simple concurrent chemoradiotherapy

Sponsors

The Fourth Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.For the newly diagnosed patients, radiotherapy and chemotherapy were not performed before the start of the clinical trial; 2.Cervical cancer confirmed by histopathology; 3.FIGO stage IB3, IIA2, IIB-IVA patients in 2018; 4.There are lesions measurable according to RECIST 1.1 standard; 5.Aged 18-70 years; 6.PS score 0-1. 7.Serum hemoglobin >=100*10^9/L, blood platelet >= 100000/µL, absolute count of neutrophils>=1500/µL; 8.Serum creatinine = 60 ml/min; 9.Serum bilirubin 6 months.

Exclusion criteria

Exclusion criteria: 1.Patients with cognitive impairment; 2.Patients with any distant metastases; 3.Patients with any other malignancy within 5 years; 4.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; 6.Severe bone marrow dysfunction; 7.Patients with bleeding tendency; 8.Drug abusers or alcohol addicts; 9.Those who are known to have a third or fourth degree allergic reaction to any treatment in the study.

Design outcomes

Primary

MeasureTime frame
OS;PFS;

Secondary

MeasureTime frame
DMFS;LCR;acute toxicity;Long-term toxicity;living quality;ORR;

Countries

China

Contacts

Public ContactFeng Chengjun

The Fourth Affiliated Hospital of Guangxi Medical University

leymj@163.com+86 18877279562

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026