NCT04727242已完成2 期
Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Hemoglobin (HGB) ≥ 9 g/dL.
- •White blood cell count (WBC) ≥ 3.0 K/ul.
- •Absolute neutrophil count (ANC) ≥ 1.5 K/ul.
- •Platelets (PLT) ≥ 100 K/ul.
- •Total bilirubin within normal institutional limits.
- •Serum glutamic oxaloacetic transaminase (SGOT/Serum glutamic pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN).
- •Creatinine < 1.5 x ULN or creatinine clearance > 60 mL/min according to Cockroft Gault formula.
- •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.
- •Serum albumin ≥ 2.5 g/dL.
- •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
排除标准
- •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.
- •Prior treatment with dacarbazine.
- •Active infection requiring antibiotics.
- •Unresolved toxic effects of prior therapy (except alopecia). Resolution is considered ≤ Grade 1 per NCI CTCAE, version 5.
- •Breast feeding.
- •Presence of metastatic liver disease
研究组 & 干预措施
Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Experimental
- 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
干预措施: Gemcitabine (Drug)
Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Experimental
- 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
干预措施: Dacarbazine (Drug)
Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Experimental
- 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
干预措施: Gadolinium (Drug)
Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Experimental
- 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
干预措施: Functional Assessment of Cancer Therapy (FACT) G questionnaire (Behavioral)
Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Experimental
- 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
干预措施: Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan (Procedure)
Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine
Experimental
- 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
干预措施: Cytoreductive Surgery (Procedure)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 1 year
Progression free survival as measured from the time of surgery until death or disease progression.
次要结局
- Rate of Grade 4 infections(30 days post surgery with gemcitabine HIPEC)
- Intraabdominal relapse free survival(12 months)
- Overall Functional Assessment of Cancer Therapy: General (FACT G) score(Baseline, 4 to 6 weeks post-surgery with HIPEC)
研究者
研究点 (2)
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