Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSIONIV)

Seoul National University

Status: Enrolling

Conditions: Uterine Cancer; Cervical Cancer

Treatments: Procedure: Uterine cancer; Procedure: Cervical cancer; Procedure: Non-cervical cancer, pelvic sidewall invasion; Procedure: Cervical cancer, pelvic sidewall invasion

Study type: Interventional

Funder types: Other

Identifiers

NCT02986568

2015-1616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 4 patient groups

Cervical cancer

Experimental group

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

Treatment:

Procedure: Cervical cancer

Uterine cancer

Experimental group

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

Treatment:

Procedure: Uterine cancer

Cervical cancer, pelvic sidewall invasion

Experimental group

Description:

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

Treatment:

Procedure: Cervical cancer, pelvic sidewall invasion

Non-cervical cancer, pelvic sidewall invasion

Experimental group

Description:

* 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

Treatment:

Procedure: Non-cervical cancer, pelvic sidewall invasion