Study of Adjuvant Chemotherapy After Neoadjuvant Chemotherapy and Surgery in Women with Locally Advanced Cervical Cancer Not Meeting NCCN Adjuvant Treatment Guidelines

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.

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