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

Launched by HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jan 30, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of additional chemotherapy in women with locally advanced cervical cancer who did not meet specific treatment guidelines after initial chemotherapy and surgery. The study focuses on patients whose tumors are larger than 4 centimeters and who are in certain stages of cervical cancer. After undergoing 2 to 3 cycles of initial chemotherapy and surgery, eligible participants will be randomly assigned to either receive more chemotherapy or just have follow-up visits. The main goal of the trial is to see how well this additional treatment helps prevent cancer from coming back over a five-year period.

To be eligible, participants must be women aged 18 to 70 with a confirmed diagnosis of cervical cancer, specifically in stages IB3 to IIB, and with a tumor size greater than 4 cm. They should also be in good overall health and able to follow the study's rules. Throughout the trial, participants will be monitored for their health and quality of life. This study aims to provide valuable information for improving treatment options for cervical cancer patients who may not qualify for standard therapies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter \> 4cm before treatment.
• • 2. Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
• • 3. Age：18-70 years old.
• • 4. ECOG status score ≤1;
• • 5. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
• • 6. Well-compliance and willing to keep in touch.
• • 7. Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.
• Exclusion Criteria:
• • 1. After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
• • 2. Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
• • 3. Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
• • 4. Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
• • 5. Participate in other clinical trials.
• • 6. Severe diseases of other important systems and organs.
• • 7. Persons without disposing capacity.
• • 8. Drug and/or alcohol abuse.
• • 9. Unable or unwilling to sign informed consents.
• • 10. Not eligible for the study judged by researchers.