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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

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

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

NCT ID

NCT02986568

First Posted

October 16, 2016

Last Updated

July 22, 2020

Sponsor

Seoul National University Hospital

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

Arm Title

Uterine cancer

Arm Type

Experimental

Arm Description

Arm Title

Cervical cancer, pelvic sidewall invasion

Arm Type

Experimental

Arm Description

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

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

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

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

soojin.mdpark@gmail.com

First Name & Middle Initial & Last Name & Degree

Hee Seung Kim, MD

Phone

82-2-2072-4863

bboddi0311@gmail.com

First Name & Middle Initial & Last Name & Degree

Hee Seung Kim, MD

12. IPD Sharing Statement

Plan to Share IPD

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4417035

Citation

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

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