CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma

NCT ID: NCT04727242

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2026-05-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine

• 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

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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

Intervention Type: DRUG

Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV

Cytoreductive Surgery

Intervention Type: PROCEDURE

Surgery for cancer removal

Functional Assessment of Cancer Therapy (FACT) G questionnaire

Intervention Type: BEHAVIORAL

Preoperative and Postoperative FACT G questionnaire to assess QoL

Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan

Intervention Type: PROCEDURE

Radiologic imaging after Cycle 3 and 6 and at each follow up visit

Gadolinium

Intervention Type: DRUG

Contrast Agent

Interventions

Gemcitabine

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.

Intervention Type: DRUG

Dacarbazine

Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV

Intervention Type: DRUG

Cytoreductive Surgery

Surgery for cancer removal

Intervention Type: PROCEDURE

Functional Assessment of Cancer Therapy (FACT) G questionnaire

Preoperative and Postoperative FACT G questionnaire to assess QoL

Intervention Type: BEHAVIORAL

Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan

Radiologic imaging after Cycle 3 and 6 and at each follow up visit

Intervention Type: PROCEDURE

Gadolinium

Contrast Agent

Intervention Type: DRUG

Other Intervention Names

Gemzar; Infugem; difluorodeoxycytidine hydrochloride; Dimethyl (triazeno) imidazolecarboxamide; Dacarbazine - DTIC; Biocarbazine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristen N Ganjoo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

SARCOMA0045

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2021-03258

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-56728

Identifier Type: -

Identifier Source: org_study_id