Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Resection rate for all patients starting SBRT
研究概览
简要总结
Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).
A Danish phase II study.
详细描述
Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT.
The sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect.
A resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies.
To ensure 25 evaluable patients the investigators will include a total of 30 patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LAPC (Karolinska Type B, C or D1)
- •Cytologically or histologically verified adenocarcinoma/carcinoma
- •Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease
- •The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)
- •World Health Organization performance status 0-1
- •Age ≥ 18 years
- •Adequate hepatic function: bilirubin <3.0 x Upper Normal Limit, International Normalized Ratio <1.6, Activated Partial Thromboplastin Time < 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy
- •Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.
排除标准
- •M1 disease
- •Prior radiotherapy to abdominal cavity
- •Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives
- •Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)
结局指标
主要结局
Resection rate for all patients starting SBRT
时间窗: 12 month
Resection rate for all patients starting SBRT
次要结局
- 1 year survival for all patients starting SBRT(12 month)
- Adverse events grade 2-5 (NCI-CTCAE 4.1)(12 month)
- Overall survival (OS)(12 month)
- Progression-free survival (PFS)(12 month)
- Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)(30 days)
- Mortality(90 days)
研究者
Per Pfeiffer
Professor, MD, PhD
Odense University Hospital