Actively Recruiting
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Do Not Meet NCCN Criteria for Additional Treatment After Neoadjuvant Chemotherapy and Surgery
Led by Huazhong University of Science and Technology · Updated on 2021-02-02
340
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Huazhong University of Science and Technology
Lead Sponsor
W
Women's Hospital School Of Medicine Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the benefit of adjuvant chemotherapy in women with locally advanced cervical cancer who have undergone neoadjuvant chemotherapy combined with surgery but do not meet criteria for additional treatment according to NCCN guidelines. This phase 3 randomized controlled trial focuses on patients with cervical cancer stages IB3, IIA2, or IIB with tumor size greater than 4 cm. The main goal is to measure disease-free survival over five years, along with overall survival, safety, and quality of life outcomes. Participants will first receive 2-3 cycles of neoadjuvant chemotherapy followed by extensive surgery involving hysterectomy and pelvic lymphadenectomy, with precautions to seal cervical cancer areas before vaginal dissection. After surgery, those not requiring adjuvant therapy per NCCN guidelines are randomly assigned to either receive adjuvant chemotherapy or no further intervention. The adjuvant chemotherapy group receives at least 2 cycles of chemotherapy drugs (paclitaxel or docetaxel plus cisplatin or carboplatin) every 21 days, with additional cycles based on certain risk factors, up to a maximum of 6 cycles. During the study, participants will be monitored for disease recurrence, survival status, quality of life, and treatment-related toxicities over a five-year period. Researchers will collect data on treatment safety and patient well-being. Participants are expected to maintain contact and comply with study procedures, including signing informed consent and completing follow-up visits to assess long-term outcomes and the overall impact of adjuvant chemotherapy compared to observation.
CONDITIONS
Brief Title
Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Clinical stage IB3 to IIB cervical cancer with tumor diameter greater than 4 cm before treatment
- Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- ECOG performance status score of 0 or 1
- Adequate blood counts and organ function within specified limits
- Willingness to comply with study requirements and maintain contact
- Able to provide informed consent
You will not qualify if you...
- Not undergoing laparotomic or laparoscopic extensive hysterectomy plus pelvic lymph node dissection after 2-3 cycles of neoadjuvant chemotherapy
- Receiving neoadjuvant chemotherapy regimens different from postoperative adjuvant therapy
- Presence of postoperative high risk factors such as lymph node metastasis, parauterine infiltration, or positive surgical margins
- Meeting Sedlis criteria for adjuvant therapy per NCCN guidelines
- Participation in other clinical trials
- Severe diseases of major organs or systems
- Lack of legal capacity to consent
- History of drug or alcohol abuse
- Unable or unwilling to provide informed consent
- Judged ineligible by researchers
AI-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 - Up to 18 weeks depending on number of chemotherapy cycles
Participants in the experimental group receive at least 2 cycles of adjuvant chemotherapy. Additional cycles (up to a maximum of 6) may be given based on risk factors after surgery. Participants in the control group receive no intervention.
Chemotherapy visits every 21 days for 2 to 6 cycles
Duration - Up to 5 years
Participants are monitored for disease-free survival, overall survival, quality of life, and incidence of toxicity for up to 5 years after treatment.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
D
Ding Ma, M.D., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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