Comparing 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)
This study is testing whether a new type of surgery can help women with cervical and uterine cancers feel better and live longer compared to standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02986568 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy of standard treatment versus fusion ontogenetic surgery for patients with cervical and uterine cancers. The approach involves a prospective comparison of treatment responses, adverse effects, and survival outcomes. The fusion ontogenetic surgery combines the advantages of the Fujii method and ontogenetic surgery, focusing on preserving pelvic organ function while reducing the need for radiation therapy. Patients eligible for this study include those with primary, recurrent, or refractory gynecologic cancers that may benefit from extensive surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are females aged 20 and older with specific stages of cervical or uterine cancer who have no other treatment options aside from surgery.
Not a fit: Patients under 20 years old, those with advanced ECOG performance status, or those who have previously undergone radical surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with gynecologic cancers.
How similar studies have performed: While the approach of fusion ontogenetic surgery is innovative, similar studies have shown promise in improving surgical outcomes for gynecologic cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Hee Seung Kim, MD — Seoul National University Hospital
- Study coordinator: Hee Seung Kim, MD
- Email: bboddi0311@gmail.com
- Phone: 82-2-2072-4863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.