Phase II Randomized Study: Cytoreductive Surgery (CRS) With/Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Adjuvant Chemotherapy as Initial Treatment of Ovarian, Fallopian Tube, & Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Post-operative complication rates
研究概览
简要总结
Community hospital based phase II (prospective randomized) study to evaluate the toxicity of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in newly diagnosed, otherwise untreated, advanced stage (stage III/IV) epithelial ovarian, fallopian tube, and primary peritoneal cancer.
详细描述
Primary endpoints:
- To assess the feasibility of recruitment
- Compare complication rates between the two study arms: CRS with HIPEC and CRS alone.
Secondary endpoints:
- To determine risk factors for morbidity and mortality
- Assess completion rate of 6 cycles of systemic chemotherapy
- To determine progression free survival at 24 months
- To determine overall survival at 1, 3, and 5 years
- Evaluate health related quality of life
Patients who meet study criteria will be randomized into one of two treatment arms: 1) cytoreductive surgery (CRS) with carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by IV combination chemotherapy with carboplatin and paclitaxel or 2) cytoreductive surgery (CRS) alone followed by adjuvant intraperitoneal (IP) and IV chemotherapy with combination cisplatin and paclitaxel for newly diagnosed advanced stage (stage III/IV) ovarian, fallopian tube or primary peritoneal cancer. Both study arms will receive 6 cycles of adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical presentation of ovarian, fallopian tube or primary peritoneal cancer
- •Stage III/IV disease
- •No prior treatment or significant surgery for the management of ovarian, fallopian tube, or primary peritoneal carcinoma; History of laparoscopic procedures to obtain diagnostic biopsies will be permitted in the study
- •Histological confirmation
- •Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
- •≤1 cm residual disease at the completion of the cytoreductive surgery (GOG criteria for optimally cytoreduction)
- •Bone marrow function:
- •Absolute neutrophil count (ANC) ≥1,000/mm3
- •Platelets ≥100,000/mm3
- •Hemoglobin ≥ 8.5 g/dL
- •Renal function:
- •Creatinine ≤1.5 times the upper limit of normal or a calculated creatinine clearance ≥60ml/min
- •Hepatic function:
- •Bilirubin ≤1.5 times upper limit of normal
- •Alanine aminotransferase (ALT) ≤3 times upper limit of normal
- •Aspartate aminotransferase (AST) ≤3 times upper limit of normal
- •Blood coagulation parameters:
- •Prothrombin time (PT) with International Normalized Ratio of ≤1.5 and a partial prothrombin time (PTT) ≤1.5 times upper limit of normal
- •For patients on full dose warfarin, in range International Normalized Ratio (usually between 2 and 3) and
- •Partial prothrombin time (PTT) <1.2 times upper limit of normal
- •Candidate for administration of postoperative standard platinum-based combination systemic chemotherapy (adequate bone marrow, renal, hepatic function, and blood coagulation parameters)
排除标准
- •Any prior treatment modality for the diagnosis of ovarian, fallopian tube, or primary peritoneal cancerPrior surgical attempt of cytoreductive surgery
- •Stage I/II disease
- •Presence of other invasive malignancies or evidence of other cancer within the past 3 years
- •Known active acute hepatitis and confirmed diagnosis of HIV
- •Active systemic infection that requires use of parenteral antibiotics
- •History of acute coronary syndromes (ACS), within the last 6 months, according to AHA definitions
- •New York Heart Association (NYHA) Class II or higher congestive heart failure according to American Heart Association (AHA) definitions
- •Canadian Cardiovascular Society (CCS) Class II or higher angina grade according to AHA definitions
- •Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at time of consent by cardiologist
- •History of cerebral artery disease and prior stroke according to AHA definitions in the last 6 months
- •Renal insufficiency with serum creatinine level ≥1.5 times the upper limit of normal or calculated creatinine clearance <60 ml/min
- •Patients with concurrent severe medical problems unrelated to malignancy that will preclude compliance with the study or places at an unacceptable risk for participation in the study determinate by study investigators
- •Pregnant women are excluded from this study because carboplatin is category D agent with the potential of teratogenic effects. Due to potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin, breastfeeding should be discontinued
- •Life expectancy of < 12 weeks
研究组 & 干预措施
CRS with adjuvant IV/IP chemotherapy
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Cytoreductive Surgery (CRS) (Procedure)
CRS with adjuvant IV/IP chemotherapy
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Adjuvant Chemotherapy (Drug)
CRS with adjuvant IV/IP chemotherapy
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Questionnaire (Other)
CRS with adjuvant IV/IP chemotherapy
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Paclitaxel (Drug)
CRS with adjuvant IV/IP chemotherapy
Patients undergo cytoreductive surgery (CRS) alone with IV/IP combination adjuvant chemotherapy. Day 1: IV paclitaxel (135 mg/m2), day 2: IP cisplatin (75 mg/m2), and day 8: IP paclitaxel (60 mg/m2) given every 21 days for a total of 6 cycles. Standard of care treatment. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Cisplatin (Drug)
CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Cytoreductive Surgery (CRS) (Procedure)
CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Adjuvant Chemotherapy (Drug)
CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Questionnaire (Other)
CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Hyperthermic intraperitoneal chemotherapy (Procedure)
CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Carboplatin (Drug)
CRS/HIPEC with adjuvant IV chemotherapy
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) administered using carboplatin for 90 minutes. Adjuvant systemic IV combination chemotherapy with carboplatin and paclitaxel (Carboplatin AUC 6, Paclitaxel 175mg/m2) will be given every 21 days for a total of 6 cycles. Administration of quality of life questionnaires throughout study duration of follow-up
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Post-operative complication rates
时间窗: 30 days post-operative
Compare post-operative complication rates between study arms
次要结局
- Evaluate overall survival(at 1, 3, and 5 years)
- Assessment of quality of life(Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5)
- Evaluate the rate of progression free survival(at 24 months)