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

NARecruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

May 10, 2016

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Cervical CancerUterine Cancer
Interventions
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."

Trial Locations (1)

Unknown

RECRUITING

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER

NCT02986568 - Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers | Biotech Hunter | Biotech Hunter