NCT05735145RecruitingPhase 3
Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer
A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging
Source: ClinicalTrials.gov · Last updated 21 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 24 Jun 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Fourth Affiliated Hospital of Guangxi Medical University
- Diseases
- Cervical cancer
- NCT number
- NCT05735145
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 108
- From 1 Jul 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Drug abusers or alcohol addicts
Other illness
- Patients with cognitive impairment
- 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
- Patients with bleeding tendency
- Those who are known to have a third or fourth degree allergic reaction to any treatment in the study
Other
- Patients with any distant metastases
- Severe bone marrow dysfunction
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| the Fourth Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Liuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.