Cervical CancerFUSIONIVNCT02986568
Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers
A study testing Cervical cancer, Uterine cancer and Cervical cancer, pelvic sidewall invasion in people with Cervical Cancer and Uterine Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cancer
- What is being tested?
- Cervical cancer, Uterine cancer and Cervical cancer, pelvic sidewall invasion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2016to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Soo jin Park, MD, 82-2-2072-0897, soojin.mdpark@gmail.com
Hee Seung Kim, MD, 82-2-2072-4863, bboddi0311@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Cancer, Uterine Cancer
- Being tested
- Cervical cancer, Uterine cancer, Cervical cancer, pelvic sidewall invasion, Non-cervical cancer, pelvic sidewall invasion
- Keywords
- Ontogenetic surgery, TMMR, PMMR, LEER
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical cancerProcedure or surgery
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.
Uterine cancerProcedure or surgery
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.
Cervical cancer, pelvic sidewall invasionProcedure or surgery
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.
Non-cervical cancer, pelvic sidewall invasionProcedure or surgery
Perform Fusion Laterally extended endopelvic resection (LEER).
After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer | Experimental | * 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 Receives: Procedure: Cervical cancer |
| Uterine cancer | Experimental | * 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 Receives: Procedure: Uterine cancer |
| Cervical cancer, pelvic sidewall invasion | Experimental | 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 Receives: Procedure: Cervical cancer, pelvic sidewall invasion |
| Non-cervical cancer, pelvic sidewall invasion | Experimental | * 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 Receives: Procedure: Non-cervical cancer, pelvic sidewall invasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time interval from treatment start date to disease recurrence or progression date
Measured: 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
the time interval from treatment start date to death or end of study date
Measured: From the date of treatment start until death due to any cause, assessed up to 60 months
Treatment-free interval
The time interval from treatment end date to disease recurrence or progression date
Measured: 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
the time interval from treatment start date to death or end of study date (recurrent or refractory disease)
Measured: the time interval from treatment start date to death or end of study date assessed up to 60 months
Secondary outcomes (6)
Tumor response
Tumor response after surgery, and the evaluation is based on revised RECIST version 1.1
Measured: 3 weeks after completion of ontogenetic surgery up to 6 weeks
Postoperative complications 1
Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Measured: after the ontogenetic surgery, up to 30 days
Postoperative complications 2
Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System
Measured: 31 days after the ontogenetic surgery through study completion, an average of 1 year
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
Measured: after the ontogenetic surgery, up to 30 days
Pain evaluation
Pelvic pain evaluated by numeric rating scale and morphine milligram equivalents (MME)
Measured: 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
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.
Measured: The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start10 May 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986568
- Sponsor's protocol ID
- 2015-1616
- Acronym
- FUSIONIV
- Status last verified
- Jul 2020
- First submitted
- 16 Oct 2016
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Piver MS, Rutledge F, Smith JP. Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol. 1974 Aug;44(2):265-72. No abstract available.
PubMed 4417035Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3.
PubMed 18308255Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Cho KR, Chu C, Cohn D, Crispens MA, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR 3rd, Mutch D, Fader AN, Remmenga SW, Reynolds RK, Teng N, Tillmanns T, Valea FA, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Apr;13(4):395-404; quiz 404. doi: 10.6004/jnccn.2015.0055.
PubMed 25870376Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Chan J, Cho KR, Cohn D, Crispens MA, Dupont N, Eifel PJ, Fader AN, Fisher CM, Gaffney DK, George S, Han E, Huh WK, Lurain JR 3rd, Martin L, Mutch D, Remmenga SW, Reynolds RK, Small W Jr, Teng N, Tillmanns T, Valea FA, McMillian N, Hughes M. Uterine neoplasms, version 1.2014. J Natl Compr Canc Netw. 2014 Feb;12(2):248-80. doi: 10.6004/jnccn.2014.0025.
PubMed 24586086Fujii S. Anatomic identification of nerve-sparing radical hysterectomy: a step-by-step procedure. Gynecol Oncol. 2008 Nov;111(2 Suppl):S33-41. doi: 10.1016/j.ygyno.2008.07.026. Epub 2008 Aug 27.
PubMed 18752840Kim HS, Kim TH, Suh DH, Kim SY, Kim MA, Jeong CW, Hong KS, Song YS. Success Factors of Laparoscopic Nerve-sparing Radical Hysterectomy for Preserving Bladder Function in Patients with Cervical Cancer: A Protocol-Based Prospective Cohort Study. Ann Surg Oncol. 2015;22(6):1987-95. doi: 10.1245/s10434-014-4197-1. Epub 2014 Dec 3.
PubMed 25465377Kim HS, Kim K, Ryoo SB, Seo JH, Kim SY, Park JW, Kim MA, Hong KS, Jeong CW, Song YS; FUSION Study Group. Conventional versus nerve-sparing radical surgery for cervical cancer: a meta-analysis. J Gynecol Oncol. 2015 Apr;26(2):100-10. doi: 10.3802/jgo.2015.26.2.100.
PubMed 25872891Hockel M, Horn LC, Fritsch H. Association between the mesenchymal compartment of uterovaginal organogenesis and local tumour spread in stage IB-IIB cervical carcinoma: a prospective study. Lancet Oncol. 2005 Oct;6(10):751-6. doi: 10.1016/S1470-2045(05)70324-7. Epub 2005 Sep 8.
PubMed 16198980Hockel M. Laterally extended endopelvic resection. Novel surgical treatment of locally recurrent cervical carcinoma involving the pelvic side wall. Gynecol Oncol. 2003 Nov;91(2):369-77. doi: 10.1016/s0090-8258(03)00502-x.
PubMed 14599868Hockel M, Horn LC, Einenkel J. (Laterally) extended endopelvic resection: surgical treatment of locally advanced and recurrent cancer of the uterine cervix and vagina based on ontogenetic anatomy. Gynecol Oncol. 2012 Nov;127(2):297-302. doi: 10.1016/j.ygyno.2012.07.120. Epub 2012 Aug 1.
PubMed 22864112Hockel M, Horn LC, Manthey N, Braumann UD, Wolf U, Teichmann G, Frauenschlager K, Dornhofer N, Einenkel J. Resection of the embryologically defined uterovaginal (Mullerian) compartment and pelvic control in patients with cervical cancer: a prospective analysis. Lancet Oncol. 2009 Jul;10(7):683-92. doi: 10.1016/S1470-2045(09)70100-7. Epub 2009 May 29.
PubMed 19482513Hockel M, Hentschel B, Horn LC. Association between developmental steps in the organogenesis of the uterine cervix and locoregional progression of cervical cancer: a prospective clinicopathological analysis. Lancet Oncol. 2014 Apr;15(4):445-56. doi: 10.1016/S1470-2045(14)70060-9. Epub 2014 Mar 19.
PubMed 24656439Kimmig R, Aktas B, Buderath P, Wimberger P, Iannaccone A, Heubner M. Definition of compartment-based radical surgery in uterine cancer: modified radical hysterectomy in intermediate/high-risk endometrial cancer using peritoneal mesometrial resection (PMMR) by M Hockel translated to robotic surgery. World J Surg Oncol. 2013 Aug 16;11:198. doi: 10.1186/1477-7819-11-198.
PubMed 23947937Hockel M. Long-term experience with (laterally) extended endopelvic resection (LEER) in relapsed pelvic malignancies. Curr Oncol Rep. 2015 Mar;17(3):435. doi: 10.1007/s11912-014-0435-8.
PubMed 25687807Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)
- ClinicalTrials.gov ID
- NCT02986568
- Acronym / sponsor ID
- FUSIONIV / 2015-1616
- Conditions
- Cervical Cancer, Uterine Cancer
- Keywords
- Ontogenetic surgery, TMMR, PMMR, LEER
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer | Experimental | Procedure: 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 |
| Uterine cancer | Experimental | Procedure: 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 |
| Cervical cancer, pelvic sidewall invasion | Experimental | Procedure: Cervical cancer, pelvic sidewall invasionCervical 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 |
| Non-cervical cancer, pelvic sidewall invasion | Experimental | Procedure: 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical cancerIf 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. | Procedure or surgery | Cervical cancer |
| Uterine cancerPerform 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. | Procedure or surgery | Uterine cancer |
| Cervical cancer, pelvic sidewall invasionPerform 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. | Procedure or surgery | Cervical cancer, pelvic sidewall invasion |
| Non-cervical cancer, pelvic sidewall invasionPerform Fusion Laterally extended endopelvic resection (LEER). After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type. | Procedure or surgery | Non-cervical cancer, pelvic sidewall invasion |
Primary outcome
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
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
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
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)
6 secondary outcomes
Tumor response
Time frame: 3 weeks after completion of ontogenetic surgery up to 6 weeks
Postoperative complications 1
Time frame: 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
Neurologic disturbance of low extremity
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Background: PubMed 4417035Piver MS, Rutledge F, Smith JP. Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol. 1974 Aug;44(2):265-72. No abstract available.
- Background: PubMed 18308255Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3.
- Background: PubMed 25870376Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Cho KR, Chu C, Cohn D, Crispens MA, Dorigo O, Eifel PJ, Fisher CM, Frederick P, Gaffney DK, Han E, Huh WK, Lurain JR 3rd, Mutch D, Fader AN, Remmenga SW, Reynolds RK, Teng N, Tillmanns T, Valea FA, Yashar CM, McMillian NR, Scavone JL. Cervical Cancer, Version 2.2015. J Natl Compr Canc Netw. 2015 Apr;13(4):395-404; quiz 404. doi: 10.6004/jnccn.2015.0055.
- Background: PubMed 24586086Koh WJ, Greer BE, Abu-Rustum NR, Apte SM, Campos SM, Chan J, Cho KR, Cohn D, Crispens MA, Dupont N, Eifel PJ, Fader AN, Fisher CM, Gaffney DK, George S, Han E, Huh WK, Lurain JR 3rd, Martin L, Mutch D, Remmenga SW, Reynolds RK, Small W Jr, Teng N, Tillmanns T, Valea FA, McMillian N, Hughes M. Uterine neoplasms, version 1.2014. J Natl Compr Canc Netw. 2014 Feb;12(2):248-80. doi: 10.6004/jnccn.2014.0025.
- Background: PubMed 18752840Fujii S. Anatomic identification of nerve-sparing radical hysterectomy: a step-by-step procedure. Gynecol Oncol. 2008 Nov;111(2 Suppl):S33-41. doi: 10.1016/j.ygyno.2008.07.026. Epub 2008 Aug 27.
- Background: PubMed 25465377Kim HS, Kim TH, Suh DH, Kim SY, Kim MA, Jeong CW, Hong KS, Song YS. Success Factors of Laparoscopic Nerve-sparing Radical Hysterectomy for Preserving Bladder Function in Patients with Cervical Cancer: A Protocol-Based Prospective Cohort Study. Ann Surg Oncol. 2015;22(6):1987-95. doi: 10.1245/s10434-014-4197-1. Epub 2014 Dec 3.
- Background: PubMed 25872891Kim HS, Kim K, Ryoo SB, Seo JH, Kim SY, Park JW, Kim MA, Hong KS, Jeong CW, Song YS; FUSION Study Group. Conventional versus nerve-sparing radical surgery for cervical cancer: a meta-analysis. J Gynecol Oncol. 2015 Apr;26(2):100-10. doi: 10.3802/jgo.2015.26.2.100.
- Background: PubMed 16198980Hockel M, Horn LC, Fritsch H. Association between the mesenchymal compartment of uterovaginal organogenesis and local tumour spread in stage IB-IIB cervical carcinoma: a prospective study. Lancet Oncol. 2005 Oct;6(10):751-6. doi: 10.1016/S1470-2045(05)70324-7. Epub 2005 Sep 8.
- Background: PubMed 14599868Hockel M. Laterally extended endopelvic resection. Novel surgical treatment of locally recurrent cervical carcinoma involving the pelvic side wall. Gynecol Oncol. 2003 Nov;91(2):369-77. doi: 10.1016/s0090-8258(03)00502-x.
- Background: PubMed 22864112Hockel M, Horn LC, Einenkel J. (Laterally) extended endopelvic resection: surgical treatment of locally advanced and recurrent cancer of the uterine cervix and vagina based on ontogenetic anatomy. Gynecol Oncol. 2012 Nov;127(2):297-302. doi: 10.1016/j.ygyno.2012.07.120. Epub 2012 Aug 1.
- Background: PubMed 19482513Hockel M, Horn LC, Manthey N, Braumann UD, Wolf U, Teichmann G, Frauenschlager K, Dornhofer N, Einenkel J. Resection of the embryologically defined uterovaginal (Mullerian) compartment and pelvic control in patients with cervical cancer: a prospective analysis. Lancet Oncol. 2009 Jul;10(7):683-92. doi: 10.1016/S1470-2045(09)70100-7. Epub 2009 May 29.
- Background: PubMed 24656439Hockel M, Hentschel B, Horn LC. Association between developmental steps in the organogenesis of the uterine cervix and locoregional progression of cervical cancer: a prospective clinicopathological analysis. Lancet Oncol. 2014 Apr;15(4):445-56. doi: 10.1016/S1470-2045(14)70060-9. Epub 2014 Mar 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Seung Kim, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical cancer, Uterine cancer and Cervical cancer, pelvic sidewall invasion in people with Cervical Cancer and Uterine Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Seung Kim, MD (82-2-2072-4863, bboddi0311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986568, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.