Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers
NCT ID: NCT02986568
Last Updated: 2020-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
380 participants
INTERVENTIONAL
2016-05-10
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GO SOAR1: Post-Operative Morbidity and Mortality Following Gynaecological Oncology Surgery
NCT04579861
The Efficacy of Salvage Surgery in Patients With Residual Tumor After Concurrent Chemoradiation for Locally Advanced Cervical Cancer.
NCT05749887
Development and Management of Registry in Patients With Gynecologic Cancer in Korea
NCT05912972
Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
NCT02562729
Study and Transformation of Tumor Molecular Features Screening Model of Endometrial Carcinoma Surgical Approach
NCT05894915
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cervical cancer
* Primary cervical cancer patients, FIGO stage IB1-IIB
* Refractory cervical cancer patients who do not respond to concurrent chemoradiotherapy or radiotherapy
* Recurrent cervical cancer after concurrent chemoradiotherapy or radiotherapy
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.
Uterine cancer
* Primary uterine cancer patients, FIGO stage IA, grade3, IB-IVA
* Refractory uterine cancer who does not respond to concurrent chemoradiotherapy or radiotherapy
* Recurrent uterine cancer after concurrent chemoradiotherapy or radiotherapy
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.
Cervical cancer, pelvic sidewall invasion
Cervical cancer patients showing pelvic sidewall invasion
* Primary cervical cancer
* Refractory cervical cancer patients who do not respond to concurrent chemoradiotherapy or radiotherapy
* Recurrent cervical cancer after concurrent chemoradiotherapy or radiotherapy
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.
Non-cervical cancer, pelvic sidewall invasion
* Gynecologic cancer patients other than cerivcal cancer, showing pelvic sidewall invasion with or without distant metastasis
* Patients showing uncontrolled pelvic pain due to the tumor invasion
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with primary, recurrent, or refractory cervical cancer (FIGO stage IB1-IVA), primary, recurrent, or refractory uterine cancer (FIGO stage IA, grade 3, IB-IVA), or gynecologic cancer patients showing pelvic sidewall recurrence.
* ECOG performance status 0 or 1
* Extensive surgery might be expected to cure the disease, or expected to relieve severe pelvic pain.
* Patients who signed an approved informed consent
* Patients who do not have a treatment option other than surgery.
Exclusion Criteria
* ECOG performance status ≥2
* Bilateral pelvic sidewall invasion
* Patients who had undergone radical hysterectomy, trachelectomy, or hysterectomy in case of the primary disease.
* Patients who refused to sign an informed consent
20 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hee Seung Kim
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hee Seung Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Piver MS, Rutledge F, Smith JP. Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol. 1974 Aug;44(2):265-72. No abstract available.
Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3.
Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Cho KR, Chu C, Cohn D, Crispens MA, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR 3rd, Mutch D, Fader AN, Remmenga SW, Reynolds RK, Teng N, Tillmanns T, Valea FA, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Apr;13(4):395-404; quiz 404. doi: 10.6004/jnccn.2015.0055.
Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Chan J, Cho KR, Cohn D, Crispens MA, Dupont N, Eifel PJ, Fader AN, Fisher CM, Gaffney DK, George S, Han E, Huh WK, Lurain JR 3rd, Martin L, Mutch D, Remmenga SW, Reynolds RK, Small W Jr, Teng N, Tillmanns T, Valea FA, McMillian N, Hughes M. Uterine neoplasms, version 1.2014. J Natl Compr Canc Netw. 2014 Feb;12(2):248-80. doi: 10.6004/jnccn.2014.0025.
Fujii S. Anatomic identification of nerve-sparing radical hysterectomy: a step-by-step procedure. Gynecol Oncol. 2008 Nov;111(2 Suppl):S33-41. doi: 10.1016/j.ygyno.2008.07.026. Epub 2008 Aug 27.
Kim HS, Kim TH, Suh DH, Kim SY, Kim MA, Jeong CW, Hong KS, Song YS. Success Factors of Laparoscopic Nerve-sparing Radical Hysterectomy for Preserving Bladder Function in Patients with Cervical Cancer: A Protocol-Based Prospective Cohort Study. Ann Surg Oncol. 2015;22(6):1987-95. doi: 10.1245/s10434-014-4197-1. Epub 2014 Dec 3.
Kim HS, Kim K, Ryoo SB, Seo JH, Kim SY, Park JW, Kim MA, Hong KS, Jeong CW, Song YS; FUSION Study Group. Conventional versus nerve-sparing radical surgery for cervical cancer: a meta-analysis. J Gynecol Oncol. 2015 Apr;26(2):100-10. doi: 10.3802/jgo.2015.26.2.100.
Hockel M, Horn LC, Fritsch H. Association between the mesenchymal compartment of uterovaginal organogenesis and local tumour spread in stage IB-IIB cervical carcinoma: a prospective study. Lancet Oncol. 2005 Oct;6(10):751-6. doi: 10.1016/S1470-2045(05)70324-7. Epub 2005 Sep 8.
Hockel M. Laterally extended endopelvic resection. Novel surgical treatment of locally recurrent cervical carcinoma involving the pelvic side wall. Gynecol Oncol. 2003 Nov;91(2):369-77. doi: 10.1016/s0090-8258(03)00502-x.
Hockel M, Horn LC, Einenkel J. (Laterally) extended endopelvic resection: surgical treatment of locally advanced and recurrent cancer of the uterine cervix and vagina based on ontogenetic anatomy. Gynecol Oncol. 2012 Nov;127(2):297-302. doi: 10.1016/j.ygyno.2012.07.120. Epub 2012 Aug 1.
Hockel M, Horn LC, Manthey N, Braumann UD, Wolf U, Teichmann G, Frauenschlager K, Dornhofer N, Einenkel J. Resection of the embryologically defined uterovaginal (Mullerian) compartment and pelvic control in patients with cervical cancer: a prospective analysis. Lancet Oncol. 2009 Jul;10(7):683-92. doi: 10.1016/S1470-2045(09)70100-7. Epub 2009 May 29.
Hockel M, Hentschel B, Horn LC. Association between developmental steps in the organogenesis of the uterine cervix and locoregional progression of cervical cancer: a prospective clinicopathological analysis. Lancet Oncol. 2014 Apr;15(4):445-56. doi: 10.1016/S1470-2045(14)70060-9. Epub 2014 Mar 19.
Kimmig R, Aktas B, Buderath P, Wimberger P, Iannaccone A, Heubner M. Definition of compartment-based radical surgery in uterine cancer: modified radical hysterectomy in intermediate/high-risk endometrial cancer using peritoneal mesometrial resection (PMMR) by M Hockel translated to robotic surgery. World J Surg Oncol. 2013 Aug 16;11:198. doi: 10.1186/1477-7819-11-198.
Hockel M. Long-term experience with (laterally) extended endopelvic resection (LEER) in relapsed pelvic malignancies. Curr Oncol Rep. 2015 Mar;17(3):435. doi: 10.1007/s11912-014-0435-8.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Chi DS, Franklin CC, Levine DA, Akselrod F, Sabbatini P, Jarnagin WR, DeMatteo R, Poynor EA, Abu-Rustum NR, Barakat RR. Improved optimal cytoreduction rates for stages IIIC and IV epithelial ovarian, fallopian tube, and primary peritoneal cancer: a change in surgical approach. Gynecol Oncol. 2004 Sep;94(3):650-4. doi: 10.1016/j.ygyno.2004.01.029.
Park SJ, Mun J, Lee S, Luo Y, Chung HH, Kim JW, Park NH, Song YS, Kim HS. Laterally Extended Endopelvic Resection Versus Chemo or Targeted Therapy Alone for Pelvic Sidewall Recurrence of Cervical Cancer. Front Oncol. 2021 May 25;11:683441. doi: 10.3389/fonc.2021.683441. eCollection 2021.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-1616
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.