RecruitingPhase 3NCT04733820

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

Sponsor

Huazhong University of Science and Technology

Enrollment

340 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Uterine Cervical Neoplasms

Summary

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether additional chemotherapy after surgery improves outcomes for women with locally advanced cervical cancer who underwent pre-surgery chemotherapy followed by surgery but do not meet the standard criteria for post-surgery treatment. **You may be eligible if...** - You are a woman aged 18–70 with stage IB3–IIB cervical cancer and a tumor larger than 4 cm - Your cancer type is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma - You are in good general health (ECOG performance status 0 or 1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread beyond the cervix in ways that prevent surgery - You have significant heart, kidney, or liver problems - You are pregnant - You have previously received pelvic radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdjuvant chemotherapy

Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.