NCT05749887

The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.

Salvage Surgery for Patients With Residual Disease After Concurrent Chemoradiation Therapy for Locally Advanced Cervical Cancer: A Prospective, Single-arm Clinical Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center single-arm study. The main purpose of this study is to study the efficacy of surgical treatment for patients with locally advanced cervical cancer (FIGO IB3, IIA2-IVA) who still have residual tumor after concurrent radiotherapy and chemotherapy.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	salvage surgery	Open/minimally invasive salvage surgery performed when cervical biopsy and/or PET/CT scan ( SUVmax ≥2.5 ) indicate patients with residual tumor intrapelvic 4-12 weeks after standard CCRT. Surgery type: 1. No parametrial involvement, extrafascial hysterectomy; 2. There is parametrial involvement, extensive hysterectomy(Q-MC); 3. Only bladder invasion, anterior pelvic exenteration; 4. Only rectal invasion, posterior pelvic exenteration or total pelvic exenteration; 5. Invasion of bladder and rectum, total exenteration. 6. The pelvic lymph nodes are removed at the same time when 18F -FDG PET /CT indicates that the SUVmax is ≥ 2.5.

Timeline

• Start date: 2023-08-25
• Primary completion: 2027-07-01
• Completion: 2032-12-31
• First posted: 2023-03-01
• Last updated: 2023-10-10

Locations

1 site across 1 country: China