Clinical trial · Interventional
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)
NCT02986568CI-TRIAL-00046165FUSIONIVunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Cancer | Malignant Uterine Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical cancer | Procedure | — | UNRESOLVED |
| Cervical cancer, pelvic sidewall invasion | Procedure | — | UNRESOLVED |
| Non-cervical cancer, pelvic sidewall invasion | Procedure | — | UNRESOLVED |
| Uterine cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cervical cancer
- description
- * 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
- interventionNames
- Procedure: Cervical cancer
- type
- EXPERIMENTAL
- label
- Uterine cancer
- description
- * 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
- interventionNames
- Procedure: Uterine cancer
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Female, Age ≥ 20 years * 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: * Female, Age \< 20 years * 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
References
Publications (17)
- BACKGROUNDPiver 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. PMID 4417035
- BACKGROUNDQuerleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3. PMID 18308255
- BACKGROUNDKoh 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. PMID 25870376
- BACKGROUNDKoh 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. PMID 24586086
- BACKGROUNDFujii 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. PMID 18752840
- BACKGROUNDKim 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. PMID 25465377
- BACKGROUNDKim 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.