NCT05735145 Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer
| NCT ID | NCT05735145 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fourth Affiliated Hospital of Guangxi Medical University |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 108 participants in total. It began in 2022-07-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Feng chengjun
PRINCIPAL INVESTIGATOR
The The Fourth Affiliated Hospital of Guangxi Medical University
Frequently Asked Questions
Who can join the NCT05735145 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05735145 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 108 participants.
Is NCT05735145 currently recruiting?
Yes, NCT05735145 is actively recruiting participants. Contact the research team at 13507726193@163.com for enrollment information.
Where is the NCT05735145 trial being conducted?
This trial is being conducted at Liuzhou, China.
Who is sponsoring the NCT05735145 clinical trial?
NCT05735145 is sponsored by Fourth Affiliated Hospital of Guangxi Medical University. The principal investigator is Feng chengjun at The The Fourth Affiliated Hospital of Guangxi Medical University. The trial plans to enroll 108 participants.