CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
United States17 participantsStarted 2021-01-28
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.