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.
Stage Ib3 and IIA2-IVA (FIGO2018) cervical cancer with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma.
Complete standard CCRT(Pelvic EBRT+ concurrent platinum-containing chemotherapy+ brachytherapy).
After 4-12 weeks of treatment, the cervical biopsy pathology confirmed residual cancer, or the cervical biopsy was negative, but PET /CT showed that SUVmax of the residual lesions in the cervical and/or pelvic lymph nodes were ≥ 2.5, two or more gynaecological oncologists with Grade IV operation qualification and the title of deputy director or above have gynecological examination, and the multidisciplinary team(MDT) evaluation recommended surgical treatment.
ECOG score:0 ~ 1.
The radiotherapy and chemotherapy are not completed or the radiotherapy dose is not reached.
PET /CT and/or pathological indicates that there is a distant metastasis including para-aortic lymph nodes.
Other malignancies were diagnosed within five years or needed treatments.
History of important organ transplantation.
Single group
salvage surgery
Procedure/SurgeryOpen/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.
OS
5 years overall survival
PFS
Progression-free survival
Click on the lead sponsor to view all of their trials.
