NCT05863377

Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer

The Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer But Without the Criteria for Adjuvant Radiotherapy According to NCCN Guidelines

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Patients will be randomly divided into two groups in a 1:1 ratio. The experimental group received 4 courses of paclitaxel and cisplatin (once every 3 weeks) for adjuvant chemotherapy within 4 weeks after surgery, while the control group don't not receive any adjuvant therapy but only received regular follow-up. The disease status of all patients will be evaluated within 4 weeks after the end of all treatment and every 12 weeks thereafter, including gynecological examination, laboratory indicators, imaging evaluation, and the prognosis of the two groups will be compared.

Conditions

• Cervical Cancer

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-05-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: China