CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)
3 other identifiers
interventional
17
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2021
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedNovember 25, 2025
November 1, 2025
5.3 years
January 22, 2021
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Progression free survival as measured from the time of surgery until death or disease progression.
1 year
Secondary Outcomes (4)
Rate of Grade 4 infections
30 days post surgery with gemcitabine HIPEC
Intraabdominal relapse free survival
6 months
Intraabdominal relapse free survival
12 months
Overall Functional Assessment of Cancer Therapy: General (FACT G) score
Baseline, 4 to 6 weeks post-surgery with HIPEC
Study Arms (1)
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
Interventions
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.
Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV
Surgery for cancer removal
Preoperative and Postoperative FACT G questionnaire to assess QoL
Radiologic imaging after Cycle 3 and 6 and at each follow up visit
Eligibility Criteria
You may qualify if:
- 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)
- 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.
- +3 more criteria
You may not qualify if:
- 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.
- Pregnant.
- Breast feeding.
- Presence of metastatic liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen N Ganjoo, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2021
First Posted
January 27, 2021
Study Start
January 28, 2021
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
November 25, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share