Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-04-18 @ 7:15 PM
Study NCT ID:
NCT02986568
Status:
RECRUITING
Last Update Posted:
2020-07-24
First Post:
2016-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2016-10-16', 'studyFirstSubmitQcDate': '2016-12-06', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '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', 'description': 'The time interval from treatment start date to disease recurrence or progression date'}, {'measure': 'Overall survival', 'timeFrame': 'From the date of treatment start until death due to any cause, assessed up to 60 months', 'description': 'the time interval from treatment start date to death or end of study date'}, {'measure': 'Treatment-free interval', 'timeFrame': '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', 'description': 'The time interval from treatment end date to disease recurrence or progression date'}, {'measure': 'Treatment-related survival', 'timeFrame': 'the time interval from treatment start date to death or end of study date assessed up to 60 months', 'description': 'the time interval from treatment start date to death or end of study date (recurrent or refractory disease)'}], 'secondaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': '3 weeks after completion of ontogenetic surgery up to 6 weeks', 'description': 'Tumor response after surgery, and the evaluation is based on revised RECIST version 1.1'}, {'measure': 'Postoperative complications 1', 'timeFrame': 'after the ontogenetic surgery, up to 30 days', 'description': 'Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System'}, {'measure': 'Postoperative complications 2', 'timeFrame': '31 days after the ontogenetic surgery through study completion, an average of 1 year', 'description': 'Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System'}, {'measure': 'Neurologic disturbance of low extremity', 'timeFrame': 'after the ontogenetic surgery, up to 30 days', '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'}, {'measure': 'Pain evaluation', 'timeFrame': '1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months', 'description': 'Pelvic pain evaluated by numeric rating scale and morphine milligram equivalents (MME)'}, {'measure': 'Time to normal bladder function', 'timeFrame': 'The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months', '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.\n\nThe time from the ontogentic surgery to the time of confirmation or normal bladder function.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ontogenetic surgery', 'TMMR', 'PMMR', 'LEER'], 'conditions': ['Cervical Cancer', 'Uterine Cancer']}, 'referencesModule': {'references': [{'pmid': '4417035', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18308255', 'type': 'BACKGROUND', 'citation': 'Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008 Mar;9(3):297-303. doi: 10.1016/S1470-2045(08)70074-3.'}, {'pmid': '25870376', 'type': 'BACKGROUND', 'citation': 'Koh 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.'}, {'pmid': '24586086', 'type': 'BACKGROUND', 'citation': 'Koh 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.'}, {'pmid': '18752840', 'type': 'BACKGROUND', 'citation': 'Fujii 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.'}, {'pmid': '25465377', 'type': 'BACKGROUND', 'citation': 'Kim 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.'}, {'pmid': '25872891', 'type': 'BACKGROUND', 'citation': 'Kim 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.'}, {'pmid': '16198980', 'type': 'BACKGROUND', 'citation': 'Hockel 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.'}, {'pmid': '14599868', 'type': 'BACKGROUND', 'citation': 'Hockel 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.'}, {'pmid': '22864112', 'type': 'BACKGROUND', 'citation': 'Hockel 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.'}, {'pmid': '19482513', 'type': 'BACKGROUND', 'citation': 'Hockel 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.'}, {'pmid': '24656439', 'type': 'BACKGROUND', 'citation': 'Hockel 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.'}, {'pmid': '23947937', 'type': 'BACKGROUND', 'citation': 'Kimmig 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.'}, {'pmid': '25687807', 'type': 'BACKGROUND', 'citation': 'Hockel 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.'}, {'pmid': '19097774', 'type': 'BACKGROUND', 'citation': 'Eisenhauer 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.'}, {'pmid': '15350354', 'type': 'BACKGROUND', 'citation': 'Chi DS, Franklin CC, Levine DA, Akselrod F, Sabbatini P, Jarnagin WR, DeMatteo R, Poynor EA, Abu-Rustum NR, Barakat RR. Improved optimal cytoreduction rates for stages IIIC and IV epithelial ovarian, fallopian tube, and primary peritoneal cancer: a change in surgical approach. Gynecol Oncol. 2004 Sep;94(3):650-4. doi: 10.1016/j.ygyno.2004.01.029.'}, {'pmid': '34113571', 'type': 'DERIVED', 'citation': 'Park SJ, Mun J, Lee S, Luo Y, Chung HH, Kim JW, Park NH, Song YS, Kim HS. Laterally Extended Endopelvic Resection Versus Chemo or Targeted Therapy Alone for Pelvic Sidewall Recurrence of Cervical Cancer. Front Oncol. 2021 May 25;11:683441. doi: 10.3389/fonc.2021.683441. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible.\n\nFujii 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.\n\nThis study is prospective study for fusion ontogenetic surgery that has the advantage of both Fujji method and ontogenetic surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female, Age ≥ 20 years\n* 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.\n* ECOG performance status 0 or 1\n* Extensive surgery might be expected to cure the disease, or expected to relieve severe pelvic pain.\n* Patients who signed an approved informed consent\n* Patients who do not have a treatment option other than surgery.\n\nExclusion Criteria:\n\n* Female, Age \\< 20 years\n* ECOG performance status ≥2\n* Bilateral pelvic sidewall invasion\n* Patients who had undergone radical hysterectomy, trachelectomy, or hysterectomy in case of the primary disease.\n* Patients who refused to sign an informed consent'}, 'identificationModule': {'nctId': 'NCT02986568', 'acronym': 'FUSIONIV', 'briefTitle': 'Efficacy of the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Cohort Study for Comparing the Efficacy Between the Standard Treatment and Fusion Ontogenetic Surgery for Gynecologic Cancers (FUSION Trial IV)', 'orgStudyIdInfo': {'id': '2015-1616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical cancer', 'description': '* Primary cervical cancer patients, FIGO stage IB1-IIB\n* Refractory cervical cancer patients who do not respond to concurrent chemoradiotherapy or radiotherapy\n* Recurrent cervical cancer after concurrent chemoradiotherapy or radiotherapy', 'interventionNames': ['Procedure: Cervical cancer']}, {'type': 'EXPERIMENTAL', 'label': 'Uterine cancer', 'description': '* Primary uterine cancer patients, FIGO stage IA, grade3, IB-IVA\n* Refractory uterine cancer who does not respond to concurrent chemoradiotherapy or radiotherapy\n* Recurrent uterine cancer after concurrent chemoradiotherapy or radiotherapy', 'interventionNames': ['Procedure: Uterine cancer']}, {'type': 'EXPERIMENTAL', 'label': 'Cervical cancer, pelvic sidewall invasion', 'description': 'Cervical cancer patients showing pelvic sidewall invasion\n\n* Primary cervical cancer\n* Refractory cervical cancer patients who do not respond to concurrent chemoradiotherapy or radiotherapy\n* Recurrent cervical cancer after concurrent chemoradiotherapy or radiotherapy', 'interventionNames': ['Procedure: Cervical cancer, pelvic sidewall invasion']}, {'type': 'EXPERIMENTAL', 'label': 'Non-cervical cancer, pelvic sidewall invasion', 'description': '* Gynecologic cancer patients other than cerivcal cancer, showing pelvic sidewall invasion with or without distant metastasis\n* Patients showing uncontrolled pelvic pain due to the tumor invasion', 'interventionNames': ['Procedure: Non-cervical cancer, pelvic sidewall invasion']}], 'interventions': [{'name': 'Cervical cancer', 'type': 'PROCEDURE', '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.\n\nIf tumor size \\< 5cm, perform Fusion Total mesometrial resection (TMMR)\n\nAfter 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.\n\nIf not, no adjuvant therapy.', 'armGroupLabels': ['Cervical cancer']}, {'name': 'Uterine cancer', 'type': 'PROCEDURE', 'description': 'Perform Fusion Peritoneal mesometrial resection (PMMR).\n\nAfter 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.\n\nIf not, no adjuvant therapy.', 'armGroupLabels': ['Uterine cancer']}, {'name': 'Cervical cancer, pelvic sidewall invasion', 'type': 'PROCEDURE', 'description': 'Perform Fusion Laterally extended endopelvic resection (LEER).\n\nAfter 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).\n\nIf not, no adjuvant therapy.', 'armGroupLabels': ['Cervical cancer, pelvic sidewall invasion']}, {'name': 'Non-cervical cancer, pelvic sidewall invasion', 'type': 'PROCEDURE', 'description': 'Perform Fusion Laterally extended endopelvic resection (LEER).\n\nAfter surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.', 'armGroupLabels': ['Non-cervical cancer, pelvic sidewall invasion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo jin Park, MD', 'role': 'CONTACT', 'email': 'soojin.mdpark@gmail.com', 'phone': '82-2-2072-0897'}, {'name': 'Hee Seung Kim, MD', 'role': 'CONTACT', 'email': 'bboddi0311@gmail.com', 'phone': '82-2-2072-4863'}, {'name': 'Hee Seung Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hee Seung Kim, MD', 'role': 'CONTACT', 'email': 'bboddi0311@gmail.com', 'phone': '82-2-2072-4863'}], 'overallOfficials': [{'name': 'Hee Seung Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hee Seung Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}