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

Primary Purpose

Cervical Cancer, Uterine Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cervical cancer
Uterine cancer
Cervical cancer, pelvic sidewall invasion
Non-cervical cancer, pelvic sidewall invasion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Ontogenetic surgery, TMMR, PMMR, LEER

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cervical cancer

Uterine cancer

Cervical cancer, pelvic sidewall invasion

Non-cervical cancer, pelvic sidewall invasion

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

Progression-free survival
The time interval from treatment start date to disease recurrence or progression date
Overall survival
the time interval from treatment start date to death or end of study date
Treatment-free interval
The time interval from treatment end date to disease recurrence or progression date
Treatment-related survival
the time interval from treatment start date to death or end of study date (recurrent or refractory disease)

Secondary Outcome Measures

Tumor response
Tumor response after surgery, and the evaluation is based on revised RECIST version 1.1
Postoperative complications 1
Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Postoperative complications 2
Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Neurologic disturbance of low extremity
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
Pelvic pain evaluated by numeric rating scale and morphine milligram equivalents (MME)
Time to normal bladder function
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.

Full Information

First Posted
October 16, 2016
Last Updated
July 22, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02986568
Brief Title
Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers
Acronym
FUSIONIV
Official Title
Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2016 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cancer
Keywords
Ontogenetic surgery, TMMR, PMMR, LEER

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical cancer
Arm Type
Experimental
Arm 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
Arm Title
Uterine cancer
Arm Type
Experimental
Arm 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
Arm Title
Cervical cancer, pelvic sidewall invasion
Arm Type
Experimental
Arm 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
Arm Title
Non-cervical cancer, pelvic sidewall invasion
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Cervical cancer
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Uterine cancer
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cervical cancer, pelvic sidewall invasion
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-cervical cancer, pelvic sidewall invasion
Intervention Description
Perform Fusion Laterally extended endopelvic resection (LEER). After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
The time interval from treatment start date to disease recurrence or progression date
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
Title
Overall survival
Description
the time interval from treatment start date to death or end of study date
Time Frame
From the date of treatment start until death due to any cause, assessed up to 60 months
Title
Treatment-free interval
Description
The time interval from treatment end date to disease recurrence or progression date
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
Title
Treatment-related survival
Description
the time interval from treatment start date to death or end of study date (recurrent or refractory disease)
Time Frame
the time interval from treatment start date to death or end of study date assessed up to 60 months
Secondary Outcome Measure Information:
Title
Tumor response
Description
Tumor response after surgery, and the evaluation is based on revised RECIST version 1.1
Time Frame
3 weeks after completion of ontogenetic surgery up to 6 weeks
Title
Postoperative complications 1
Description
Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Time Frame
after the ontogenetic surgery, up to 30 days
Title
Postoperative complications 2
Description
Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Time Frame
31 days after the ontogenetic surgery through study completion, an average of 1 year
Title
Neurologic disturbance of low extremity
Description
Incidence of motor and sensory disturbances of low extremities, and the grading is based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
after the ontogenetic surgery, up to 30 days
Title
Pain evaluation
Description
Pelvic pain evaluated by numeric rating scale and morphine milligram equivalents (MME)
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
Title
Time to normal bladder function
Description
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.
Time Frame
The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Seung Kim, MD
Phone
82-2-2072-4863
Email
bboddi0311@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo jin Park, MD
Phone
82-2-2072-0897
Email
soojin.mdpark@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD
Phone
82-2-2072-4863
Email
bboddi0311@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers

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