NCT05367206

Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

Department of Radiation, Sun Yat-sen University

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis.

Detailed description

in this phase III tiral , stage IIIC cervical cancer patients with carcinoma \>4 cm in greatest dimension and/or lymph node \>2cm in short axis will be randomly assigned to two circles of NAC with albumin-bound paclitaxel and carboplatin followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life.

Conditions

• Cervical Cancer
• Neoadjuvant Chemotherapy
• Bulky Neoplasm

Interventions

Type	Name	Description
DRUG	Albumin-Bound Paclitaxel	260mg/m2 q3w \*2 circles
DRUG	Carboplatin	AUC 5-6 q3w \* 2 circles

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-03-31
• Completion: 2027-03-31
• First posted: 2022-05-10
• Last updated: 2022-05-10

Locations

1 site across 1 country: China