Heated chemo during surgery may curb return of rare uterine cancer

NCT ID NCT04727242

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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