NCT02986568

Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers

Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare standard treatment and fusion ontogenetic surgery (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and survival.

Detailed description

Fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible. Fujii method has advantage of preserving pelvic autonomic nerve with radical resection of tissue under parametrium. And ontogenetic surgery has advantage of reducing need of radiation therapy by radical resection of tissue above parametrium. This study is prospective study for fusion ontogenetic surgery that has the advantage of both Fujji method and ontogenetic surgery.

Conditions

• Cervical Cancer
• Uterine Cancer

Interventions

Type	Name	Description
PROCEDURE	Cervical cancer	If tumor sized ≥ 5cm, undergo neoadjuvant chemotherapy with Cisplatin before surgery. (40mg/m2 on day 1 of each 7 day cycle for 5 cycles), then perform Fusion TMMR after neoadjuvant chemotherapy with cisplatin as above. If tumor size \< 5cm, perform Fusion Total mesometrial resection (TMMR) After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. If not, no adjuvant therapy.
PROCEDURE	Uterine cancer	Perform Fusion Peritoneal mesometrial resection (PMMR). After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. If not, no adjuvant therapy.
PROCEDURE	Cervical cancer, pelvic sidewall invasion	Perform Fusion Laterally extended endopelvic resection (LEER). After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. Patients with primary disease will be treated with adjvuant chemotherapy. In case of recurrent disease, bevacizumab, paclitaxel, and cisplaitn will be administered regardless of the pathologic report (bevacizumab 15mg/kg on day 1, paclitaxel 135mg/m2 on day 1, and cisplatin 50mg/m2 on day 2, of each 21 day cycle). If not, no adjuvant therapy.
PROCEDURE	Non-cervical cancer, pelvic sidewall invasion	Perform Fusion Laterally extended endopelvic resection (LEER). After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.

Timeline

• Start date: 2016-05-10
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2016-12-08
• Last updated: 2020-07-24

Locations

1 site across 1 country: South Korea