Heated chemo during surgery may curb return of rare uterine cancer
NCT ID NCT04727242
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested whether giving heated chemotherapy directly into the abdomen during surgery, followed by standard chemo, could help prevent uterine leiomyosarcoma from coming back. Seventeen women with locally recurrent cancer took part. The goal was to see if this combined approach improves how long patients live without the cancer progressing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine and dacarbazine
- What this could lead to
- If it works, this approach could lower the chance of uterine leiomyosarcoma coming back after surgery.
- What could go wrong
- This is a small, early-phase study with only 17 participants, so results may not apply to everyone. Heated chemotherapy also carries risks like infection and side effects from the drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
17 people
The number who actually took part.
- Started
-
Jan 2021
- Finished
-
Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of local recurrence. 2. Imaging provides evidence of locally recurrent uterine LMS. 3. Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician. 4. Age ≥ 18 years. 5. Life expectancy \> 3 months. 6. 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) 7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. 8. Hemoglobin (HGB) ≥ 9 g/dL. 9. White blood cell count (WBC) ≥ 3.0 K/ul. 10. Absolute neutrophil count (ANC) ≥ 1.5 K/ul. 11. Platelets (PLT) ≥ 100 K/ul. 12. Total bilirubin within normal institutional limits. 13. Serum glutamic oxaloacetic transaminase (SGOT/Serum glutamic pyruvic transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN). 14. Creatinine \< 1.5 x ULN or creatinine clearance \> 60 mL/min according to Cockroft Gault formula. 15. 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. 16. Serum albumin ≥ 2.5 g/dL. 17. 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 Exclusion Criteria: 1. Recurrence of LMS within less than 6 months after the last dose of gemcitabine. 2. 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. 3. Prior gemcitabine given in non adjuvant setting. 4. Prior treatment with dacarbazine. 5. Active infection requiring antibiotics. 6. Unresolved toxic effects of prior therapy (except alopecia). Resolution is considered ≤ Grade 1 per NCI CTCAE, version 5.0. 7. Pregnant. 8. Breast feeding. 9. Presence of metastatic liver disease
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for LMS - leiomyosarcoma are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Stanford University
Stanford, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.