Treatment for advanced cervical cancer using chemoradiotherapy and additional chemotherapy
A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging
This study is testing if adding extra chemotherapy to standard chemoradiotherapy can help people with advanced cervical cancer live longer and stay healthier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fourth Affiliated Hospital of Guangxi Medical University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Liuzhou, Guangxi) |
| Trial ID | NCT05735145 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of concurrent chemoradiotherapy combined with adjuvant chemotherapy in patients with locally advanced cervical cancer. It compares the outcomes of patients receiving both treatments against those receiving only chemoradiotherapy. The study utilizes advanced radiation techniques, including intensity-modulated radiation therapy and three-dimensional afterloading therapy, to enhance treatment efficacy. The aim is to clarify the role of adjuvant chemotherapy in improving disease-free and overall survival rates based on the updated 2018 FIGO staging system.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with histologically confirmed locally advanced cervical cancer at specific FIGO stages who have responded well to initial treatment.
Not a fit: Patients with cervical cancer at stages not included in the study or those who have not responded to initial treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce recurrence in patients with advanced cervical cancer.
How similar studies have performed: While concurrent chemoradiotherapy is standard, the addition of adjuvant chemotherapy remains controversial, indicating that this study could provide new insights into treatment efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Liuzhou, Guangxi
- the Fourth Affiliated Hospital of Guangxi Medical University — Liuzhou, Guangxi, China (Recruiting)
Study contacts
- Principal investigator: Feng chengjun — The The Fourth Affiliated Hospital of Guangxi Medical University
- Study coordinator: Huang haixin
- Email: 13507726193@163.com
- Phone: 13507726193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.