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ACTIVE NOT RECRUITING
NCT04723875
PHASE3

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

Sponsor: Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

306

Start Date

2021-01-28

Completion Date

2026-01-31

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

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.

Locations (3)

Tongji Hospital

Wuhan, Hubei, China

Qilu Hospital, Shandong University, 107 West Wenhua Road

Ji'nan, Shandong, China

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China