Clinical trial NCT02986568: Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers
Official title: Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Uterine Cancer
Keywords: Ontogenetic surgery
TMMR
PMMR
LEER
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 380
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of treatment start until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months
measure: Overall survival
timeFrame: From the date of treatment start until death due to any cause, assessed up to 60 months
measure: Treatment-free interval
timeFrame: From date of treatment end until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months
measure: Treatment-related survival
timeFrame: the time interval from treatment start date to death or end of study date assessed up to 60 months
Secondary outcomes:
measure: Tumor response
timeFrame: 3 weeks after completion of ontogenetic surgery up to 6 weeks
measure: Postoperative complications 1
timeFrame: after the ontogenetic surgery, up to 30 days
measure: Postoperative complications 2
timeFrame: 31 days after the ontogenetic surgery through study completion, an average of 1 year
measure: Neurologic disturbance of low extremity
timeFrame: after the ontogenetic surgery, up to 30 days
measure: Pain evaluation
timeFrame: 1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months
measure: Time to normal bladder function
timeFrame: The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, MD
role: PRINCIPAL_INVESTIGATOR
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