A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Relapse-free Survival
研究概览
简要总结
Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.
详细描述
This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
- •Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
- •Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
- •Age > 18 years.
- •Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:
- •Absolute Neutrophil Count (ANC) > 1,500/µL Platelets > 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)<2.5X institutional upper limit of normal Creatinine clearance > 60mL/min for patients with creatinine levels above institutional normal.
- •Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.
- •Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
- •Women must not be pregnant or breast-feeding.
排除标准
- •Patients receiving any other investigational agents.
- •Patients with known metastases.
- •Patients with wounds that have not fully healed.
研究组 & 干预措施
Arm 1 - FOLFIRINOX
FOLFIRINOX:
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles over 8 weeks
Chemoradiation:
Radiation to begin no sooner than 28 days from last day of chemotherapy.
On Day 1(+ 2days to accommodate scheduling difficulties):
Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.
FOLFIRINOX:
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
干预措施: FOLFIRINOX (Drug)
Arm 1 - FOLFIRINOX
FOLFIRINOX:
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles over 8 weeks
Chemoradiation:
Radiation to begin no sooner than 28 days from last day of chemotherapy.
On Day 1(+ 2days to accommodate scheduling difficulties):
Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.
FOLFIRINOX:
Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
干预措施: Chemoradiation (Radiation)
Arm 2 - Gemcitabine / Abraxane
Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks
Chemoradiation:
Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.
Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated
干预措施: Gemcitabine (Drug)
Arm 2 - Gemcitabine / Abraxane
Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks
Chemoradiation:
Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.
Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated
干预措施: Abraxane (Drug)
Arm 2 - Gemcitabine / Abraxane
Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles over 8 weeks
Chemoradiation:
Radiation to begin no sooner than 28 days from last day of chemotherapy. On Day 1 (+ 2days to accommodate scheduling difficulties) Infusional 5-FU (225 mg/m2 continuous infusion during radiation) and radiation therapy as defined.
Gemcitabine / Abraxane Gemcitabine 1000 mg/m2 Days 1, 8, 15 Abraxane 125 mg/m2 Days 1, 8, 15 Two cycles, if tolerated
干预措施: Chemoradiation (Radiation)
结局指标
主要结局
Number of Participants With Relapse-free Survival
时间窗: 20 months
In this small trial we will regard a median progression-free survival of 20 months as indicative of potential therapeutic benefit meriting additional study.
次要结局
未报告次要终点