A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
研究概览
简要总结
The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.
详细描述
Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic intraperitoneal chemotherapy with carboplatin.
Secondary Objective(s)
- To compare the quality of life in participants with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in participants treated with cytoreduction surgery and systemic chemotherapy alone.
- To describe toxicities in participants with ovarian cancer treated with second look laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy.
OUTLINE:
Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the absence of disease progression or unacceptable toxicity.
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
- •Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy
- •Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based systemic chemotherapy prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 18 weeks prior to second look surgery.
- •Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy
- •The intraoperative peritoneal adhesion index should be <
- •Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy.
- •Age ≥ 18 years.
- •ECOG performance status ≤
- •Patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal
- •Adequate contraception and negative pregnancy test if pregnancy possible.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document.
排除标准
- •Patients greater than 18 weeks from their last course of systemic platinum based chemotherapy
- •Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above.
- •Patients may not have received prior abdominal or pelvic radiation.
- •Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of >10 as defined above
- •Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnancy
- •Men are excluded from participation due to the site-specific nature of the disease being studied.
研究组 & 干预措施
Second Look Laparoscopy and HIPEC with Carboplatin
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
干预措施: Second look laparoscopy reassessment surgery (SLLRS) (Procedure)
Second Look Laparoscopy and HIPEC with Carboplatin
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
干预措施: HIPEC with Carboplatin (Drug)
Second Look Laparoscopy and HIPEC with Carboplatin
Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.
干预措施: FACT-O Quality of Life Questionnaire (Other)
结局指标
主要结局
Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy
时间窗: end of treatment
The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.
次要结局
- Number of Reported Toxicities(Up to 3 months post treatment)
- Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire(Up to 6 months post-treatment)