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

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT05863377
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-01
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-16
• Last Update Submitted: 2023-05-16
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. The age of patients is 18-70 years old.
2. Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).
3. Clinical stage is IB1-IB2 according to FIGO 2018 stage.
4. The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.
5. The degree of tumor differentiation is poorly differentiated.
6. Do not meet the Sedlis criteria or the four-factor model, but meet one of the following factors: ① LVSI (+); ② tumor diameter > 2cm; ③ Depth of cervical stromal invasion > superficial 1/3; (4) adenocarcinoma.

Exclusion Criteria

1. Postoperative pathological stage ≥IIA (according to the 2018 FIGO staging system).
2. Patients with the following high risk factors: ① lymph node metastasis; ② parametrial involvement; ③ positive surgical margin; ④ vaginal involvement.
3. Patients received neoadjuvant chemotherapy.
4. There was evidence of distant metastasis on preoperative imaging examination.
5. Patients received postoperative radiotherapy.
6. History of abdominal or pelvic radiotherapy.
7. Patients with other malignant tumors.
8. Patients with missing or partially missing clinical, surgical, and pathological data were lost to follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progress Free Survival (PFS)	5 years	The time between surgery and clinical recurrence.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	5 years	The time interval between the cancer diagnosis and the death of any reason.

Trial Locations

Locations (1)

The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universit; 🇨🇳 Guangzhou, Guangdong, China