Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)

Who is this study for? Adult female patients with Stage IB1 to IVA Primary, Recurrent, or Refractory Cervical Cancer or Stage IA, grade 3, or IB to IVA Uterine Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Hee Seung Kim, MD
bboddi0311@gmail.com
82-2-2072-4863
Time Frame
Start Date: 2016-05-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 380
Treatments
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov