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

NCT02986568 | Unknown DMC

• 1 other identifier: 2015-1616
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Uterine Cancer

Keywords

Ontogenetic surgery; TMMR; PMMR; LEER

Outcome Measures

Primary Outcomes (4)

• Progression-free survival

  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

  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

  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

  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 Outcomes (6)

• Tumor response

  3 weeks after completion of ontogenetic surgery up to 6 weeks

• Postoperative complications 1

  after the ontogenetic surgery, up to 30 days

• Postoperative complications 2

  31 days after the ontogenetic surgery through study completion, an average of 1 year

• Neurologic disturbance of low extremity

  after the ontogenetic surgery, up to 30 days

• Pain evaluation

  1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months

Study Arms (4)

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

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

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

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

Procedure: Non-cervical cancer, pelvic sidewall invasion

Interventions

Cervical cancer PROCEDURE

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.

Cervical cancer

Uterine cancer PROCEDURE

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.

Uterine cancer

Cervical cancer, pelvic sidewall invasion PROCEDURE

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.

Cervical cancer, pelvic sidewall invasion

Non-cervical cancer, pelvic sidewall invasion PROCEDURE

Perform Fusion Laterally extended endopelvic resection (LEER). After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.

Non-cervical cancer, pelvic sidewall invasion

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (17)

• 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: 4417035 BACKGROUND

• 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: 18308255 BACKGROUND

• 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: 25870376 BACKGROUND

• 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: 24586086 BACKGROUND

• 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: 18752840 BACKGROUND

• 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: 25465377 BACKGROUND

• 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: 25872891 BACKGROUND

• 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: 16198980 BACKGROUND

• 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: 14599868 BACKGROUND

• 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: 22864112 BACKGROUND

• 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: 19482513 BACKGROUND

• 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: 24656439 BACKGROUND

• 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: 23947937 BACKGROUND

• 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: 25687807 BACKGROUND

• 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: 19097774 BACKGROUND

• 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: 15350354 BACKGROUND

• 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.

  PMID: 34113571 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hee Seung Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Seung Kim, MD

CONTACT

82-2-2072-4863; bboddi0311@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: December 8, 2016
• Study Start: May 10, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)