Combined CRS With HIPEC in Women With Inadvertently Morcellated uLMS

NCT06678763 | Completed

• 1 other identifier: SYSKY-2024-939-01
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with benign tumors who undergo hysterectomy or myomectomy, minimally invasive gynecologic surgery (MIGS) has advantages over traditional laparotomy such as less trauma and faster recovery. The application of comminution technology is helpful for the implementation of MIGS. Uterine leiomyosarcoma (uLMS) is a malignant tumor that is difficult to diagnose preoperatively and is highly invasive. It is often diagnosed as a benign tumor before surgery. Occult uLMS will cause peritoneal dissemination after non-protective comminution surgery, leading to catastrophic outcomes and extremely poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is an important method for the treatment of peritoneal disseminated tumors and has been used in the treatment of gastrointestinal tumors and ovarian cancer. Recent studies have reported that it can significantly improve the progression-free survival (PFS) and overall survival (OS) rates of patients with recurrent uLMS and peritoneal metastasis. However, the efficacy and safety of this treatment for patients with accidental non-protective comminution of uLMS remain uncertain. This study will conduct a retrospective study to evaluate the efficacy and safety of CRS-HIPEC as the first-line treatment for accidentally morcellated uLMS.

Conditions

Uterine Leiomyosarcoma

Keywords

Cytoreductive surgery; Hyperthermic intraperitoneal chemotherapy; Morcellation; Uterine leiomyosarcoma;

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  Time from completion of CRS-HIPEC to disease recurrence

  From completion of CRS-HIPEC to disease recurrence, assessed up to 120 months

• Overall survival (OS)

  Time from completion of CRS-HIPEC to death of any cause

  From completion of CRS-HIPEC to death of any cause, assessed up to 120 months

Secondary Outcomes (1)

• Adverse Events (AE)

  up to 3 weeks after CRS-HIPEC

Study Arms (1)

CRS-HIPEC

The patient received open laparotomy cytoreduction surgery in the same principle as epithelial ovarian cancer surgery, and received intraperitoneal hyperthermic chemotherapy with docetaxel (75 mg/m²) and gemcitabine (1000 mg/m²) within 24 hours after surgery.

Procedure: CRS-HIPEC

Interventions

CRS-HIPEC PROCEDURE

Patients with uterine leiomyosarcoma who received unprotected morcellation were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with docetaxel and gemcitabine.

CRS-HIPEC

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with uterine leiomyosarcoma who received unprotected morcellation were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with docetaxel and gemcitabine.

You may qualify if:

• Patients who underwent myomectomy or hysterectomy for presumed benign disease and used non-protected morcellation and were subsequently pathologically diagnosed with uterine leiomyosarcoma.
• Patients underwent open laparotomy with similar surgical principles to epithelial ovarian cancer and achieved complete resection (R0 resection)
• Patients received closed hyperthermic intraperitoneal chemotherapy with docetaxel + gemcitabine after surgery.

You may not qualify if:

• Patients who received chemotherapy or radiotherapy previously.
• Incomplete follow-up data

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (5)

• Matsuzaki S, Matsuzaki S, Chang EJ, Yasukawa M, Roman LD, Matsuo K. Surgical and oncologic outcomes of hyperthermic intraperitoneal chemotherapy for uterine leiomyosarcoma: A systematic review of literature. Gynecol Oncol. 2021 Apr;161(1):70-77. doi: 10.1016/j.ygyno.2020.12.032. Epub 2021 Jan 6.

  PMID: 33419612 BACKGROUND

• Xu X, Lin H, Wright JD, Gross CP, Boscoe FP, Hutchison LM, Schwartz PE, Desai VB. Association Between Power Morcellation and Mortality in Women With Unexpected Uterine Cancer Undergoing Hysterectomy or Myomectomy. J Clin Oncol. 2019 Dec 10;37(35):3412-3424. doi: 10.1200/JCO.19.00562. Epub 2019 Sep 16.

  PMID: 31518176 BACKGROUND

• Graebe K, Garcia-Soto A, Aziz M, Valarezo V, Heller PB, Tchabo N, Tobias DH, Salamon C, Ramieri J, Dise C, Slomovitz BM. Incidental power morcellation of malignancy: a retrospective cohort study. Gynecol Oncol. 2015 Feb;136(2):274-7. doi: 10.1016/j.ygyno.2014.11.018. Epub 2014 Nov 26.

  PMID: 25740603 BACKGROUND

• Senapati S, Tu FF, Magrina JF. Power morcellators: a review of current practice and assessment of risk. Am J Obstet Gynecol. 2015 Jan;212(1):18-23. doi: 10.1016/j.ajog.2014.07.046. Epub 2014 Jul 26.

  PMID: 25072737 BACKGROUND

• Rayburn WF. Minimally Invasive Gynecologic Surgery: Improving Outcomes and Recovery While Reducing Discomfort and Cost. Obstet Gynecol Clin North Am. 2022 Jun;49(2):xiii-xiv. doi: 10.1016/j.ogc.2022.04.002. No abstract available.

  PMID: 35636816 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 7, 2024
• Study Start: January 1, 2016
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)