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| ID | Type | Description | Link |
|---|---|---|---|
| SARCOMA0045 | Other Identifier | OnCore | |
| NCI-2021-03258 | Other Identifier | CTRP |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Progression free survival as measured from the time of surgery until death or disease progression. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Grade 4 infections | Rate of Grade 4 infections within 30 days post surgery with gemcitabine HIPEC will be assessed using CTCAE version 5.0. | 30 days post surgery with gemcitabine HIPEC |
| Intraabdominal relapse free survival |
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Inclusion Criteria:
Note that this study does not allow the use of a legally authorized representative
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen N Ganjoo, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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|
| Dacarbazine | Drug | Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV |
|
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| Cytoreductive Surgery | Procedure | Surgery for cancer removal |
|
| Functional Assessment of Cancer Therapy (FACT) G questionnaire | Behavioral | Preoperative and Postoperative FACT G questionnaire to assess QoL |
|
| Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan | Procedure | Radiologic imaging after Cycle 3 and 6 and at each follow up visit |
|
| Gadolinium | Drug | Contrast Agent |
|
Relapse free survival as measured from time of surgery until intraabdominal recurrence
| 6 months |
| Intraabdominal relapse free survival | Relapse free survival as measured from time of surgery until intraabdominal recurrence | 12 months |
| Overall Functional Assessment of Cancer Therapy: General (FACT G) score | Difference in overall FACT G score from baseline to 4 to 6 weeks post-surgery with gemcitabine HIPEC. FACT G is a quality of life questionnaire composed of 27 items divided into four main quality of life categories: Physical Well Being (PWB); Social/Family Well Being (SWB); Emotional Well Being (EWB); and Functional Well Being (FWB). Total FACT G score is obtained by summing the scores from the four main QoL categories (PWB; SWB; EWB; FWB). The range of the scale is 0-108. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better Quality of life (Qol). | Baseline, 4 to 6 weeks post-surgery with HIPEC |
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D003606 | Dacarbazine |
| D065426 | Cytoreduction Surgical Procedures |
| D009682 | Magnetic Resonance Spectroscopy |
| D005682 | Gadolinium |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013514 | Surgical Procedures, Operative |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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