LMS - LeiomyosarcomaPhase 2NCT04727242
CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
A Phase 2 study testing Gemcitabine, Dacarbazine and Cytoreductive Surgery in people with LMS - Leiomyosarcoma and Uterine Leiomyosarcoma, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to find out if giving a dose of heated chemotherapy in the abdomen immediately after surgery that is done to remove uterine leiomyosarcoma type of cancer will help lower the risk of the cancer coming back in the future. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- LMS - Leiomyosarcoma, Uterine Leiomyosarcoma
- What is being tested?
- Gemcitabine, Dacarbazine and Cytoreductive Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 11 Feb 2026
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of local recurrence.
- Imaging provides evidence of locally recurrent uterine LMS.
- Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician.
- Age ≥ 18 years.
- Life expectancy > 3 months.
- Women of childbearing potential (WOCBP) will have a negative pregnancy test ≤ 7 days prior to surgery (this test can be omitted if subject is post menopausal by either surgery or elevated FSH)
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- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Hemoglobin (HGB) ≥ 9 g/dL.
- White blood cell count (WBC) ≥ 3.0 K/ul.
- Absolute neutrophil count (ANC) ≥ 1.5 K/ul.
- Platelets (PLT) ≥ 100 K/ul.
- Total bilirubin within normal institutional limits.
- Serum glutamic oxaloacetic transaminase (SGOT/Serum glutamic pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN).
- Creatinine < 1.5 x ULN or creatinine clearance > 60 mL/min according to Cockroft Gault formula.
- Prothrombin Time (PT) such that international normalized ratio (INR) is < 1.5 (or an in range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control.
- Serum albumin ≥ 2.5 g/dL.
- Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
- Note that this study does not allow the use of a legally authorized representative
Who cannot join
- Recurrence of LMS within less than 6 months after the last dose of gemcitabine.
- Active extra abdominal disease including active malignant pleural effusion. Subjects who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included.
- Prior gemcitabine given in non adjuvant setting.
- Prior treatment with dacarbazine.
- Active infection requiring antibiotics.
- Unresolved toxic effects of prior therapy (except alopecia). Resolution is considered ≤ Grade 1 per NCI CTCAE, version 5.0.
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- Pregnant.
- Breast feeding.
- Presence of metastatic liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)
The purpose of this study is to find out if giving a dose of heated chemotherapy in the abdomen immediately after surgery that is done to remove uterine leiomyosarcoma type of cancer will help lower the risk of the cancer coming back in the future.
Read the detailed description
Primary Objective:
- To assess the efficacy of cytoreductive surgery with gemcitabine HIPEC followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterine LMS.
Secondary Objectives:
- To assess the safety of cytoreductive surgery with gemcitabine HIPEC in subjects with locally recurrent uterine LMS.
- To assess the 6 month and 12 month intraabdominal relapse free survival in subjects with locally recurrent uterine LMS
- To determine quality of life prior to therapy (within 28 days prior to surgery with HIPEC), 4 to 6 weeks after surgery with HIPEC, and then at Cycle
- Conditions
- LMS - Leiomyosarcoma, Uterine Leiomyosarcoma
- Being tested
- Gemcitabine, Dacarbazine, Cytoreductive Surgery, Functional Assessment of Cancer Therapy (FACT) G questionnaire, Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar, Infugem, difluorodeoxycytidine hydrochloride
Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine. Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C.
DacarbazineDrug
Also called Dimethyl (triazeno) imidazolecarboxamide, Dacarbazine - DTIC, Biocarbazine
Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV
Cytoreductive SurgeryProcedure or surgery
Surgery for cancer removal
Functional Assessment of Cancer Therapy (FACT) G questionnaireBehavioural
Preoperative and Postoperative FACT G questionnaire to assess QoL
Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) ScanProcedure or surgery
Radiologic imaging after Cycle 3 and 6 and at each follow up visit
GadoliniumDrug
Contrast Agent
| Study group | Role | What they receive |
|---|---|---|
| Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine | Experimental | * Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine followed by postoperative systemic chemotherapy with dacarbazine. Conceptually, HIPEC will be administered as a 60 minute heated intraperitoneal infusion (ie, intraperitoneal "wash" or "lavage").
* HIPEC: Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C.
* Systemic adjuvant chemotherapy starting 30 days ± 14 days post surgery. Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles Receives: Drug: Gemcitabine; Drug: Dacarbazine; Procedure: Cytoreductive Surgery; Behavioral: Functional Assessment of Cancer Therapy (FACT) G questionnaire; Procedure: Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan; Drug: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression free survival as measured from the time of surgery until death or disease progression.
Measured: 1 year
Secondary outcomes (4)
Rate of Grade 4 infections
Rate of Grade 4 infections within 30 days post surgery with gemcitabine HIPEC will be assessed using CTCAE version 5.0.
Measured: 30 days post surgery with gemcitabine HIPEC
Intraabdominal relapse free survival
Relapse free survival as measured from time of surgery until intraabdominal recurrence
Measured: 6 months
Intraabdominal relapse free survival
Relapse free survival as measured from time of surgery until intraabdominal recurrence
Measured: 12 months
Overall Functional Assessment of Cancer Therapy: General (FACT G) score
Difference in overall FACT G score from baseline to 4 to 6 weeks post-surgery with gemcitabine HIPEC.
FACT G is a quality of life questionnaire composed of 27 items divided into four main quality of life categories: Physical Well Being (PWB); Social/Family Well Being (SWB); Emotional Well Being (EWB); and Functional Well Being (FWB). Total FACT G score is obtained by summing the scores from the four main QoL categories (PWB; SWB; EWB; FWB). The range of the scale is 0-108. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better Quality of life (Qol).
Measured: Baseline, 4 to 6 weeks post-surgery with HIPEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start28 Jan 2021
- Primary completion28 Jan 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LMS - LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen N Ganjoo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727242
- Sponsor's protocol ID
- IRB-56728
- Other IDs
- SARCOMA0045, NCI-2021-03258
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)
- ClinicalTrials.gov ID
- NCT04727242
- Acronym / sponsor ID
- IRB-56728
- Conditions
- LMS - Leiomyosarcoma, Uterine Leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 27 Jan 2021 (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.
The purpose of this study is to find out if giving a dose of heated chemotherapy in the abdomen immediately after surgery that is done to remove uterine leiomyosarcoma type of cancer will help lower the risk of the cancer coming back in the future.
Detailed description
Primary Objective:
- To assess the efficacy of cytoreductive surgery with gemcitabine HIPEC followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterine LMS.
Secondary Objectives:
- To assess the safety of cytoreductive surgery with gemcitabine HIPEC in subjects with locally recurrent uterine LMS.
- To assess the 6 month and 12 month intraabdominal relapse free survival in subjects with locally recurrent uterine LMS
- To determine quality of life prior to therapy (within 28 days prior to surgery with HIPEC), 4 to 6 weeks after surgery with HIPEC, and then at Cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine | Experimental | Drug: Gemcitabine, Drug: Dacarbazine, Procedure: Cytoreductive Surgery, Behavioral: Functional Assessment of Cancer Therapy (FACT) G questionnaire, Procedure: Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan, Drug: Gadolinium* Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine followed by postoperative systemic chemotherapy with dacarbazine. Conceptually, HIPEC will be administered as a 60 minute heated intraperitoneal infusion (ie, intraperitoneal "wash" or "lavage"). * HIPEC: Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C. * Systemic adjuvant chemotherapy starting 30 days ± 14 days post surgery. Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of local recurrence.
- Imaging provides evidence of locally recurrent uterine LMS.
- Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician.
- Age ≥ 18 years.
- Life expectancy > 3 months.
Key exclusion criteria (9 listed)
- Recurrence of LMS within less than 6 months after the last dose of gemcitabine.
- Active extra abdominal disease including active malignant pleural effusion. Subjects who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included.
- Prior gemcitabine given in non adjuvant setting.
- Prior treatment with dacarbazine.
- Active infection requiring antibiotics.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar, Infugem, difluorodeoxycytidine hydrochlorideHyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine. Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C. | Drug | Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine |
| DacarbazineAlso: Dimethyl (triazeno) imidazolecarboxamide, Dacarbazine - DTIC, BiocarbazineDacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV | Drug | Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine |
| Cytoreductive SurgerySurgery for cancer removal | Procedure or surgery | Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine |
| Functional Assessment of Cancer Therapy (FACT) G questionnairePreoperative and Postoperative FACT G questionnaire to assess QoL | Behavioural | Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine |
| Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) ScanRadiologic imaging after Cycle 3 and 6 and at each follow up visit | Procedure or surgery | Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine |
| GadoliniumContrast Agent | Drug | Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine |
Primary outcome
Progression free survival (PFS)
Time frame: 1 year
Progression free survival as measured from the time of surgery until death or disease progression.
4 secondary outcomes
Rate of Grade 4 infections
Time frame: 30 days post surgery with gemcitabine HIPEC
Intraabdominal relapse free survival
Time frame: 6 months
Intraabdominal relapse free survival
Time frame: 12 months
Overall Functional Assessment of Cancer Therapy: General (FACT G) score
Time frame: Baseline, 4 to 6 weeks post-surgery with 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 25 Jun 2026.
- 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.
Kristen N Ganjoo, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Dacarbazine and Cytoreductive Surgery in people with LMS - Leiomyosarcoma and Uterine Leiomyosarcoma, run by Stanford University at 1 site in United States.
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 18 inclusion and 9 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 25 Jun 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.