Pancreatic Locally Advanced Irresectable Cancer Ablation; a Randomized Controlled Superiority Phase III Multicenter Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The aim of the PELICAN trial is to investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC after 2 months of induction chemotherapy.
详细描述
Pancreatic cancer is the fifth leading cause of cancer-related death in the Netherlands. Each year around 900 patients in the Netherlands are diagnosed with irresectable locally advanced pancreatic cancer (LAPC), which has a median survival of 7.9 months. Standard treatment is palliative chemotherapy, which offers only a very limited survival benefit. Radiofrequency ablation (RFA) is a new ablative technique for LAPC, which is feasible and safe and has been suggested to improve survival. A randomized controlled trial has not yet been performed.
The aim of the PELICAN trial is to investigate the survival benefit of RFA plus standard palliative chemotherapy as compared to palliative chemotherapy alone in patients with LAPC after 2 months of induction chemotherapy. In a randomized controlled parallel-group superiority multicenter phase III clinical trial.
The intervention will be RFA followed by chemotherapy (gemcitabine monotherapy, nab-paclitaxel plus gemcitabine or FOLFIRINOX). The comparison will be standard palliative treatment consisting of gemcitabine monotherapy, nab-gemcitabine plus gemcitabine or FOLFIRINOX Primary endpoint: Overall survival. Secondary endpoints: Progression free survival, complications, pain, radiological tumor response, CA-19.9 and CEA response, quality of life, immunomodulation and total direct and indirect costs.
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
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Locally irresectable tumor
- •Primary tumor
- •Stable disease or partial response after 2 months of induction chemotherapy (according to RECIST)
- •Fit for chemotherapy as assessed by the medical oncologist, plus:
- •Absolute neutrophil count: 1.5 × 109/L
- •Platelet count: 100 × 109/L
- •Renal function: creatinine clearance> 50 ml/min
- •Transaminases ≤ 3 x ULN
- •Fit for surgery assessed by the treating surgeon and anesthesiologist
- •RFA technical feasible
- •Written informed consent
- •Age ≥ 18 years
- •Expert panel approval for randomisation
排除标准
- •WHO performance status ≥ 3
- •Distant metastases on abdominal or thoracic CT scan*
- •Previous surgical, local ablative or radiotherapy for pancreatic cancer or chemotherapy which is inconsistent with the prescribed induction schedule according to protocol**
- •Stenosis of > 50% of the hepatic artery AND stenosis of >50% of the portal vein/ superior mesenteric vein
- •Second primary malignancy, except adequately treated non-melanoma skin cancer, in situ carcinoma of the cervix uteri or other malignancies treated at least 5 years previously without signs of recurrence.
- •Positive regional lymph nodes metastases are not a reason for exclusion. Lymph nodes are considered as regional, according to the consensus statement by the International Study Group of Pancreatic Surgery (ISGPS). Suspicious lymph nodes only on radiologic basis are not considered as metastasis. Only when suspicion is high due to large infiltration, pathological examination by FNA can be considered.
- •Surgical exploration is not a contra-indication for inclusion
研究组 & 干预措施
RFA
RFA: laparotomy is performed followed by radiofrequency ablation of the tumor.
After recovery of the RFA patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel + gemcitabine or gemcitabine monotherapy
干预措施: Radiofrequency ablation (RFA) (Procedure)
RFA
RFA: laparotomy is performed followed by radiofrequency ablation of the tumor.
After recovery of the RFA patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel + gemcitabine or gemcitabine monotherapy
干预措施: FOLFIRINOX (Drug)
RFA
RFA: laparotomy is performed followed by radiofrequency ablation of the tumor.
After recovery of the RFA patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel + gemcitabine or gemcitabine monotherapy
干预措施: Nab-paclitaxel plus Gemcitabine (Drug)
RFA
RFA: laparotomy is performed followed by radiofrequency ablation of the tumor.
After recovery of the RFA patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel + gemcitabine or gemcitabine monotherapy
干预措施: Gemcitabine (Drug)
Chemotherapy
Patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy
干预措施: FOLFIRINOX (Drug)
Chemotherapy
Patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy
干预措施: Nab-paclitaxel plus Gemcitabine (Drug)
Chemotherapy
Patients will continue chemotherapy:
FOLFIRINOX or nab-paclitaxel plus gemcitabine or gemcitabine monotherapy
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: 1.5 years
The period of time between randomization and death from any cause
次要结局
- Tumor marker response(1.5 years)
- Quality of Life questionnaire(1.5 years)
- Progression free survival(1.5 years)
- Radiological tumor response(1.5 years)
- Complications(1.5 years)
研究者
I.Q. Molenaar
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)