Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers
- Conditions
- Cervical CancerUterine Cancer
- Interventions
- Procedure: Cervical cancerProcedure: Uterine cancerProcedure: Non-cervical cancer, pelvic sidewall invasionProcedure: Cervical cancer, pelvic sidewall invasion
- Registration Number
- NCT02986568
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 380
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cervical cancer 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 Uterine cancer 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 Non-cervical cancer, pelvic sidewall invasion 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 Cervical cancer, pelvic sidewall invasion 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
- Primary Outcome Measures
Name Time Method Treatment-free interval 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 The time interval from treatment end date to disease recurrence or progression date
Overall survival From the date of treatment start until death due to any cause, assessed up to 60 months the time interval from treatment start date to death or end of study date
Treatment-related survival the time interval from treatment start date to death or end of study date assessed up to 60 months the time interval from treatment start date to death or end of study date (recurrent or refractory disease)
Progression-free survival 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 The time interval from treatment start date to disease recurrence or progression date
- Secondary Outcome Measures
Name Time Method Postoperative complications 2 31 days after the ontogenetic surgery through study completion, an average of 1 year Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Tumor response 3 weeks after completion of ontogenetic surgery up to 6 weeks Tumor response after surgery, and the evaluation is based on revised RECIST version 1.1
Time to normal bladder function The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months In case of bladder preservation, normal bladder function is evaluated by residual urine check after time voiding, and the volume of residual urine is less than 100cc.
The time from the ontogentic surgery to the time of confirmation or normal bladder function.Neurologic disturbance of low extremity after the ontogenetic surgery, up to 30 days Incidence of motor and sensory disturbances of low extremities, and the grading is based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Pain evaluation 1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months Pelvic pain evaluated by numeric rating scale and morphine milligram equivalents (MME)
Postoperative complications 1 after the ontogenetic surgery, up to 30 days Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of