Actively Recruiting
A Prospective Randomized Controlled Trial for Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy in the Treatment of Advanced Cervical Cancer at 2018 FIGO Staging
Led by Fourth Affiliated Hospital of Guangxi Medical University · Updated on 2023-02-21
108
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness of combining concurrent chemoradiotherapy with adjuvant chemotherapy versus concurrent chemoradiotherapy alone in treating locally advanced cervical cancer. This prospective, randomized controlled trial focuses on patients staged according to the 2018 FIGO system. The study aims to clarify the role of additional chemotherapy after standard intensity-modulated radiation therapy and three-dimensional afterloading treatment, addressing the ongoing debate about its benefits for disease-free and overall survival. Participants receive either concurrent intensity-modulated radiotherapy combined with chemotherapy followed by adjuvant chemotherapy using paclitaxel combined with platinum, or concurrent chemoradiotherapy alone. Treatment is delivered using advanced radiation techniques that improve biological effects compared to traditional methods. Patients who achieve complete response after initial treatment are randomized to either receive the additional chemotherapy or be observed without it. During the study, participants will be closely monitored for disease progression and survival outcomes, with progression-free survival as the primary measure and overall survival as a secondary measure. Assessments include regular clinical evaluations, laboratory tests, and imaging as per clinical standards. The study follows patients over an extended period, up to 1000 months, to gather long-term data on treatment impact and safety. The trial is sponsored by the Fourth Affiliated Hospital of Guangxi Medical University and is expected to complete by mid-2027.
CONDITIONS
Brief Title
Concurrent Chemoradiotherapy Combined With Adjuvant Chemotherapy Treated Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cervical cancer confirmed by histopathology including squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma
- FIGO stage IB3, IIA2, IIB-IVA patients in 2018
- Locally advanced cervical cancer patients who received standard concurrent intensity-modulated chemoradiotherapy followed by three-dimensional afterloading treatment and achieved complete response after treatment
- Aged 18 to 75 years
- Performance status score 0-1
- Serum hemoglobin >=100*10^9/L, blood platelet >= 100000/µL, absolute neutrophil count >=1500/µL
- Serum creatinine <=1.5 UNL or creatinine clearance >= 60 ml/min
- Serum bilirubin <=1.5 UNL, AST (SGOT) and ALT (SGPT) <= 1.5 UNL
- Signed informed consent confirming understanding of study and policies
- Estimated total survival greater than 6 months
You will not qualify if you...
- Locally advanced cervical cancer patients who did not achieve complete response after standard concurrent intensity-modulated chemoradiotherapy and three-dimensional afterloading 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 condition contraindicating chemoradiotherapy (e.g., active infection, recent myocardial infarction within 6 months, symptomatic heart disease, immunosuppressive therapy)
- Pregnant or lactating women, or fertile women not using contraception
- Severe bone marrow dysfunction
- Patients with bleeding tendency
- Drug abusers or alcohol addicts
- Known severe allergic reactions to any study treatments
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration as per standard treatment protocol
Participants receive standard concurrent intensity-modulated chemoradiotherapy combined with three-dimensional afterloading treatment.
Multiple visits during treatment period
Duration - As per chemotherapy cycles defined in protocol
Participants who achieved complete response after concurrent chemoradiotherapy receive adjuvant chemotherapy with paclitaxel combined with platinum.
Multiple visits for chemotherapy administration and monitoring
Duration - Up to study completion
Participants who do not receive adjuvant chemotherapy are observed after concurrent chemoradiotherapy.
Regular follow-up visits as per protocol
Trial Site Locations
Total: 1 location
1
the Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi, China, 545005
Actively Recruiting
Research Team
H
Huang haixin
F
Feng chengjun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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