NCT04723875

Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline

Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline: A Prospective Multicenter Randomized Controlled Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients who undergo radical surgery but do not meet criteria of adjuvant therapy according to NCCN guideline are enrolled to receive adjuvant chemotherapy. The primary endpoint was disease-free survival (DFS) rate at 3 year. The secondary endpoints were 5-year DFS, overall survival (OS) and safety.

Conditions

• Uterine Cervical Neoplasms
• Cervical Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-28
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2021-01-26
• Last updated: 2024-11-01

Locations

3 sites across 1 country: China