跳至主要内容
临床试验/NCT05043857
NCT05043857进行中(未招募)不适用

Stereotactic PAncreatic RadioTherapy Adjuvant Therapy (SPARTA): Phase II Trial.

Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
2
主要终点
Local Recurrence Rate

研究概览

简要总结

While surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically <25%. Following surgical resection of pancreatic cancer, adjuvant conventionally fractionated RT (CRT, delivering 45-54 Gy in 1.8-2.0 Gy per fraction) with 5-FU chemotherapy is recommended in high-risk patients (positive lymph nodes and/or R1-R2 resection margin status). However, the benefit of CRT in this setting is controversial due to lack of prospective positive data. Moreover, duration of treatment course (delaying initiation of more effective chemotherapy schedules), insufficient dose delivery due potential radiation-related severe toxicity to proximity organs represents a serious limitation to treatment efficacy. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.

详细描述

Pancreatic carcinoma is expected to become in the next 10 years the second leading cause of cancer-related mortality. Resection is the only treatment with the potential to achieve long-term survival, although expected survival at 5 year is <25%: postoperative use of local and systemic adjuvant treatments has been proposed to improve outcome While the efficacy of adjuvant chemotherapy, in parrticular multiagent chemotherapy, has been established, the potential impact of chemoradiation in the adjuvant setting is still controversial. However, its use in patients with high risk features such as nodal involvement and close or positive margins may be of interest.

Adjuvant chemoradiation, when clinically indicated, is usually delivered in a 6 week treatment course in association with concurrent dose-adapted chemotherapy, implying the necessity to interrupt more effective multi-agent chemotherapy schedules due to risk of increased toxicity.

It has been proposed that higher radiotherapy doses may result in improved outcome although a potential detrimental effect on survival of dose escalation >55 Gy with conventional fractionation, possibly related to increased toxicity, has been reported. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course. In a retrospective study by Rwigema et al, adjuvant pancreatic SBRT was shown to be a safe and feasible treatment option for patients with high-risk pancreatic adenocarcinoma.

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

入选标准

  • Surgically treated T1-T4 adenocarcinoma with or without prior chemotherapy AND close (<2.5mm)/positive resection margin AND/OR N1 staging at lymphadenectomy
  • ECOG performance status <2
  • Age > 18
  • Estimated life expectancy > 6 months
  • Ability to provide written informed consent
  • Cardiovascular comorbidities limiting life expectancy

排除标准

  • Metastatic disease
  • Biliary tract or neuroendocrine neuroplasm
  • History of malignancies except for non-melanoma cutaneous tumors

结局指标

主要结局

Local Recurrence Rate

时间窗: 1 year

local recurrence rate in operated pancreatic cancer patients following adjuvant SBRT

次要结局

  • Overall Survival(1 year)
  • disease-free interval(1 year)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验