A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Complete resection rate
研究概览
简要总结
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.
详细描述
The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with resectable pancreatic adenocarcinoma
- •Age over 18 years old and younger than 70 year old
- •Performance status (ECOG scale): 0-1
- •Adequate organ functions
- •Hb ≥9.0 g/dl
- •ANC ≥1,500/mm3
- •PLT ≥100,000/mm3
- •Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
- •Creatinine ≤1.5 ULN
- •Patients should sign a written informed consent before study entry.
排除标准
- •Tumor type other than adenocarcinoma
- •Unresectable for resection on preoperative evaluation
- •Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- •Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
- •Prior radiotherapy
- •Major surgery within 4 weeks prior to study treatment
- •Serious illness or medical conditions, as follows;
- •congestive heart failure (NYHA class III or IV)
- •unstable angina or myocardial infarction within the past 6 months,
- •significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- •uncontrolled hypertension
- •hepatic cirrhosis( ≥ Child class B)
- •interstitial pneumonia, pulmonary adenomatosis
- •psychiatric disorder that may interfere with and/or protocol compliance
- •unstable diabetes mellitus
- •uncontrolled ascites or pleural effusion
- •active infection
- •Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
- •Pregnant or lactating woman
- •Women of child bearing potential not using a contraceptive method
- •Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- •Any patients judged by the investigator to be unfit to participate in the study
研究组 & 干预措施
Radiation: chemoradiotherapy with Gemcitabine
Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.
干预措施: Radiation: chemoradiotherapy with Gemcitabine (Radiation)
结局指标
主要结局
Complete resection rate
时间窗: Within the first 30 days after surgery
To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
次要结局
- Clinical outcomes(Up to 3years from a initial follow-up)
- The feasibility and compliance(Up to 1 year)
- The association between biomolecular markers and clinical outcomes(Up to 3years until study closed)
研究者
Sang-Jae Park
Principal Investigator
National Cancer Center, Korea