Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery
Summary
This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.
Timeline
- Start
- 2021-02-01
- Primary completion
- 2028-02-01
- Completion
- 2028-02-01
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 | — |