drugset / Trial / NCT04723875
Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline
Phase 3
Active not recruiting
306 enrolled
Huazhong University of Science and Technology
First Affiliated Hospital of Chongqing Medical University · collabHunan Cancer Hospital · collabObstetrics & Gynecology Hospital of Fudan University · collabQilu Hospital of Shandong University · collabThe Third Xiangya Hospital of Central South University · collabWomen's Hospital School Of Medicine Zhejiang University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-01-28
- Primary completion
- 2026-01-31
- Completion
- 2026-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 70 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | — |