A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Although FOLFIRINOX regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating resectable pancreatic cancer patients in China. Since for many tumors, different races may show different responses to the same regimen, we design this open phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for resectable pancreatic cancer in China.
详细描述
This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months.
Primary endpoint is the disease free survival. Secondary endpoints are overall survival, safety and quality of life.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
- •Receive radical resection of pancreatic cancer
- •No prior cytostatic chemotherapy
- •Female and male patients > 18 and <=79 years using contraception
- •Patient has adequate bone marrow and organ function
- •Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L Platelets ≥ 90 x 109/L Hemoglobin ≥ 90 g/L
- •Patient has adequate liver function AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 1.2 x ULN Creatinine ≤ 1.25 times ULN
- •Good compliance
- •Written informed consent
排除标准
- •Pregnant or lactating women
- •Distant metastasis.
- •Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
- •Refuse to take appropriate contraceptive measures (including male patients).
- •Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
- •Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
- •Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
- •Psychiatric illness that would prevent the patient from giving informed consent.
- •Patient is concurrently using other antineoplastic agent
- •Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
- •Known HIV-positivity.
- •No history of chronic diarrhea, nausea or vomit.
- •No ≥ grade 2 sensory peripheral neuropathy.
- •A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
- •Infectious disease or inflammation with body temperature ≥ 38 ℃.
研究组 & 干预措施
FOLFIRINOX
Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
干预措施: Folfirinox (Drug)
结局指标
主要结局
Disease free survival
时间窗: up to 24 months
From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first
次要结局
- Overall survival(up to 24 months)
研究者
Yuhong Li
Professor
Sun Yat-sen University