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

July 22, 2020 updated by: Hee Seung Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

380

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Cervical cancer

If tumor sized ≥ 5cm, undergo neoadjuvant chemotherapy with Cisplatin before surgery. (40mg/m2 on day 1 of each 7 day cycle for 5 cycles), then perform Fusion TMMR after neoadjuvant chemotherapy with cisplatin as above.

If tumor size < 5cm, perform Fusion Total mesometrial resection (TMMR)

After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy.

If not, no adjuvant therapy.
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
Procedure: Uterine cancer

Perform Fusion Peritoneal mesometrial resection (PMMR).

After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy.

If not, no adjuvant therapy.
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
Procedure: Cervical cancer, pelvic sidewall invasion

Perform Fusion Laterally extended endopelvic resection (LEER).

After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. Patients with primary disease will be treated with adjvuant chemotherapy. In case of recurrent disease, bevacizumab, paclitaxel, and cisplaitn will be administered regardless of the pathologic report (bevacizumab 15mg/kg on day 1, paclitaxel 135mg/m2 on day 1, and cisplatin 50mg/m2 on day 2, of each 21 day cycle).

If not, no adjuvant therapy.
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
Procedure: Non-cervical cancer, pelvic sidewall invasion

Perform Fusion Laterally extended endopelvic resection (LEER).

After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 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
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
Overall survival
Time Frame: 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
From the date of treatment start until death due to any cause, assessed up to 60 months
Treatment-free interval
Time Frame: 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
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
Treatment-related survival
Time Frame: 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)
the time interval from treatment start date to death or end of study date assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 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
3 weeks after completion of ontogenetic surgery up to 6 weeks
Postoperative complications 1
Time Frame: 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
after the ontogenetic surgery, up to 30 days
Postoperative complications 2
Time Frame: 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
31 days after the ontogenetic surgery through study completion, an average of 1 year
Neurologic disturbance of low extremity
Time Frame: 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
after the ontogenetic surgery, up to 30 days
Pain evaluation
Time Frame: 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)
1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months
Time to normal bladder function
Time Frame: 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.
The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee Seung Kim, MD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 16, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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