Uterine LeiomyosarcomaNCT06678763
Combined CRS With HIPEC in Women With Inadvertently Morcellated uLMS
An observational study of Uterine Leiomyosarcoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Leiomyosarcoma
- What is being tested?
- CRS-HIPEC
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 30 Jun 2024
- Phase
- Observational
- 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 Any age
- Women only
- Child, Adult, Older adult
Study population: Patients with uterine leiomyosarcoma who received unprotected morcellation were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with docetaxel and gemcitabine.
Who may be able to join
- 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.
Who cannot join
- Patients who received chemotherapy or radiotherapy previously.
- Incomplete follow-up data
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120
About this study
Official title: Combined Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy in Women With Inadvertently Morcellated Uterine Leiomyosarcoma: a Registry Study From a Tertiary Referral Hospital
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.
Read the detailed description
For patients undergoing hysterectomy or myomectomy for benign uterine tumors, minimally invasive gynecologic surgery (MIGS) has the advantages of fewer complications and faster recovery time compared with traditional laparotomy. Morcellation techniques, which are used to pulverize the uterus or myoma, facilitate the implementation of MIGS, especially for women with large uteruses or myomas or who are nulliparous. However, the safety of morcellation techniques has been controversial since the US Food and Drug Administration (FDA) issued a warning in 2014. The main concern is that unprotected morcellation may spread tissue fragments throughout the abdominal cavity. If a malignancy is present, such as uterine leiomyosarcoma (uLMS)-a highly invasive tumor that is difficult to diagnose preoperatively-this spread can have catastrophic consequences. The 5-year disease-specific survival rate for patients with uLMS who undergo unprotected morcellation is only 25.3%, while the 5-year disease-specific survival rate for patients who undergo complete tumor resection is 62.6%. Although the FDA recommends the use of tissue containment systems during laparoscopic morcellation, implementation of this recommendation varies worldwide, and endobag devices (tissue protection bags) are not universally available. Therefore, the management of peritoneal uLMS that disseminate after unprotected morcellation remains a major clinical challenge.
Hyperthermic intraperitoneal chemotherapy (HIPEC) is an important method for the treatment of peritoneal disseminated tumors. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has shown efficacy in the treatment of peritoneal carcinomatosis in gastrointestinal and ovarian cancers. Recent studies have reported that it can significantly improve progression-free survival (PFS) and overall survival (OS) rates in patients with recurrent uLMS with peritoneal metastasis. A meta-analysis of 13 cases of recurrent uLMS conducted by Matsuzaki et al. in 2021 showed that the 3-year progression-free survival (PFS) and overall survival (OS) rates of patients who received CRS-HIPEC were 71.4% and 75.0%, respectively, compared with 0% and 50.1% for patients who received CRS alone. However, the efficacy and safety of this treatment for patients with accidentally comminuted uLMS remain uncertain.
In 2016, Sun Yat-sen Memorial Hospital of Sun Yat-sen University established a HIPEC program to routinely perform tumor reduction surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for patients with comminuted uLMS. Due to the limited availability of the HIPEC program outside our center, the HIPEC PROGRAM registry system was established to help refer patients from external institutions and receive CRS-HIPEC treatment. This study will conduct a retrospective study through the registration system, with patients who underwent unprotected morcellation surgery for occult uLMS and received CRS-HIPEC treatment as the research subjects, with progression-free survival (PFS) and overall survival (OS) as the primary outcomes, and the incidence of HIPEC-related ≥ grade 3 adverse events (AEs) as the secondary outcome, to evaluate the efficacy and safety of CRS-HIPEC as the first-line treatment for accidentally morcellated uLMS.
- Conditions
- Uterine Leiomyosarcoma
- Being tested
- CRS-HIPEC
- Keywords
- Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Morcellation, Uterine leiomyosarcoma;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRS-HIPECProcedure or surgery
Patients with uterine leiomyosarcoma who received unprotected morcellation were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with docetaxel and gemcitabine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CRS-HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from completion of CRS-HIPEC to disease recurrence
Measured: 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
Measured: From completion of CRS-HIPEC to death of any cause, assessed up to 120 months
Secondary outcomes (1)
Adverse Events (AE)
he adverse events would be graded according to Memorial Sloan-Kettering Cancer Center surgical secondary events (MSK SSE) grading system. The types and incidence of AEs will be recorded to evaluate the safety of CRS-HIPEC
Measured: up to 3 weeks after CRS-HIPEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jan 2016
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uterine LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678763
- Sponsor's protocol ID
- SYSKY-2024-939-01
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33419612Xu 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.
PubMed 31518176Graebe 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.
PubMed 25740603Senapati 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.
PubMed 25072737Rayburn 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.
PubMed 35636816
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy in Women With Inadvertently Morcellated Uterine Leiomyosarcoma: a Registry Study From a Tertiary Referral Hospital
- ClinicalTrials.gov ID
- NCT06678763
- Acronym / sponsor ID
- SYSKY-2024-939-01
- Conditions
- Uterine Leiomyosarcoma
- Keywords
- Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Morcellation, Uterine leiomyosarcoma;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Nov 2024 (actual)
- 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.
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.
Detailed description
For patients undergoing hysterectomy or myomectomy for benign uterine tumors, minimally invasive gynecologic surgery (MIGS) has the advantages of fewer complications and faster recovery time compared with traditional laparotomy. Morcellation techniques, which are used to pulverize the uterus or myoma, facilitate the implementation of MIGS, especially for women with large uteruses or myomas or who are nulliparous. However, the safety of morcellation techniques has been controversial since the US Food and Drug Administration (FDA) issued a warning in 2014. The main concern is that unprotected morcellation may spread tissue fragments throughout the abdominal cavity. If a malignancy is present, such as uterine leiomyosarcoma (uLMS)-a highly invasive tumor that is difficult to diagnose preoperatively-this spread can have catastrophic consequences. The 5-year disease-specific survival rate for patients with uLMS who undergo unprotected morcellation is only 25.3%, while the 5-year disease-specific survival rate for patients who undergo complete tumor resection is 62.6%. Although the FDA recommends the use of tissue containment systems during laparoscopic morcellation, implementation of this recommendation varies worldwide, and endobag devices (tissue protection bags) are not universally available. Therefore, the management of peritoneal uLMS that disseminate after unprotected morcellation remains a major clinical challenge.
Hyperthermic intraperitoneal chemotherapy (HIPEC) is an important method for the treatment of peritoneal disseminated tumors. Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has shown efficacy in the treatment of peritoneal carcinomatosis in gastrointestinal and ovarian cancers. Recent studies have reported that it can significantly improve progression-free survival (PFS) and overall survival (OS) rates in patients with recurrent uLMS with peritoneal metastasis. A meta-analysis of 13 cases of recurrent uLMS conducted by Matsuzaki et al. in 2021 showed that the 3-year progression-free survival (PFS) and overall survival (OS) rates of patients who received CRS-HIPEC were 71.4% and 75.0%, respectively, compared with 0% and 50.1% for patients who received CRS alone. However, the efficacy and safety of this treatment for patients with accidentally comminuted uLMS remain uncertain.
In 2016, Sun Yat-sen Memorial Hospital of Sun Yat-sen University established a HIPEC program to routinely perform tumor reduction surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for patients with comminuted uLMS. Due to the limited availability of the HIPEC program outside our center, the HIPEC PROGRAM registry system was established to help refer patients from external institutions and receive CRS-HIPEC treatment. This study will conduct a retrospective study through the registration system, with patients who underwent unprotected morcellation surgery for occult uLMS and received CRS-HIPEC treatment as the research subjects, with progression-free survival (PFS) and overall survival (OS) as the primary outcomes, and the incidence of HIPEC-related ≥ grade 3 adverse events (AEs) as the secondary outcome, to evaluate the efficacy and safety of CRS-HIPEC as the first-line treatment for accidentally morcellated uLMS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRS-HIPEC | – | Procedure: CRS-HIPECThe 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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with uterine leiomyosarcoma who received unprotected morcellation were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with docetaxel and gemcitabine.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who received chemotherapy or radiotherapy previously.
- Incomplete follow-up data
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 |
|---|---|---|
| CRS-HIPECPatients with uterine leiomyosarcoma who received unprotected morcellation were treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy with docetaxel and gemcitabine. | Procedure or surgery | CRS-HIPEC |
Primary outcome
Progression Free Survival (PFS)
Time frame: From completion of CRS-HIPEC to disease recurrence, assessed up to 120 months
Time from completion of CRS-HIPEC to disease recurrence
Overall survival (OS)
Time frame: From completion of CRS-HIPEC to death of any cause, assessed up to 120 months
Time from completion of CRS-HIPEC to death of any cause
1 secondary outcome
Adverse Events (AE)
Time frame: up to 3 weeks after CRS-HIPEC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Background: PubMed 33419612Matsuzaki 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.
- Background: PubMed 31518176Xu 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.
- Background: PubMed 25740603Graebe 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.
- Background: PubMed 25072737Senapati 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.
- Background: PubMed 35636816Rayburn 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Leiomyosarcoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Nov 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: From completion of CRS-HIPEC to disease recurrence, assessed up to 120 months). The study lists 2 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 NCT06678763, which also lists 5 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 7 Nov 2024.