A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- UMC Utrecht
- 入组人数
- 174
- 试验地点
- 6
- 主要终点
- Survival after recurrence
研究概览
简要总结
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with isolated local pancreatic ductal adenocarcinoma (PDAC) recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are treatment response, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastases free survival and reasons for non-eligibility or exclusion.
详细描述
Rationale: Disease recurrence remains the main cause of mortality in patients who underwent resection for PDAC. In case of recurrence, patients are currently treated with palliative chemotherapy or best supportive care. In 20-30% of all patients, isolated local PDAC recurrence occurs after resection, which is frequently associated with considerable morbidity from local destructive tumor growth. Although survival after recurrence is predominantly determined by systemic disease, additional local ablative therapy might be of value to improve local disease control in these patients, which could positively affect survival and quality of life (QoL). Previously, radiation therapy has played only a minor role in the treatment of PDAC. As the pancreas is tightly surrounded by organs with limited radiation dose tolerance and subjected to abdominal motion due to respiration and peristalsis, optimal dose delivery has been impeded with conventional radiotherapy techniques. The development of image-guided stereotactic body radiation therapy (SBRT) techniques, however, enabled safe delivery of high irradiation doses to pancreatic lesions. Early retrospective studies have suggested that SBRT might lead to improved local control in patients with isolated local PDAC recurrence, potentially having a beneficial effect on both survival and QoL. In the current, multicenter randomized controlled trial, the value of SBRT in addition to standard of care in patients with isolated local PDAC recurrence is compared to standard of care alone, with regard to both survival and quality of life outcomes.
Objective: The main objective of this study is to improve survival after recurrence in patients with isolated local PDAC recurrence using local ablative treatment with SBRT in addition to standard of care. Furthermore, the effects of additional SBRT on QoL will be evaluated within this study.
Study design: A randomized controlled trial, nested within a prospective cohort (PACAP) according to the TwiCs design.
Study population: PACAP-participants with isolated local PDAC recurrence after primary resection who provided informed consent for being randomized in future studies.
Intervention: Local ablative therapy (5 times 8 Gray SBRT) in addition to standard of care.
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
- •Participation in the PACAP cohort with written informed consent for being randomized in future studies
- •Isolated local recurrence after primary PDAC resection
- •Minimum age of 18 years
排除标准
- •Distant metastases
- •Expected lifespan < 3 months
- •Ineligibility for MRI or CT according to the protocol of the local radiology department;
- •Highly selective cases with resectable, isolated local recurrence without the need for either systemic or local ablative induction therapy, eligible for re-resection according to the expert panel.
研究组 & 干预措施
Additional stereotactic body radiation therapy
SBRT in addition to standard of care.
干预措施: Additional stereotactic body radiation therapy (Radiation)
Standard of care
Treatment according to current clinical practice.
结局指标
主要结局
Survival after recurrence
时间窗: From the date of PDAC recurrence diagnosis until either death from any cause or last follow-u, whichever came first, assessed up to 24 months
The interval between the date of PDAC recurrence diagnosis and either death from any cause or last follow-up.
次要结局
- Patient reported cancer-specific HRQoL as assessed using the EORTC QLQ-C30(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Treatment response assessed on CT-imaging (graded according to RECIST guidelines)(During and immediately after the intervention (SBRT treatment))
- Acute and late toxicity of SBRT as assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0(Through study completion, an average of 18 months)
- Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Patient reported non-disease specific health-related Quality of Life (HRQoL) as assessed using the EQ-5D-5L(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)(At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months)
- Overall survival(From the date of primary resection until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months)
- Distant metastases free survival(From the date of disease recurrence until the date that distant progression of disease occurs, assessed up to 18 months)
- Reasons for non-eligibility or exclusion for SBRT treatment(At the time the patient is assessed eligible for the intervention. Assessed through the study, up to 18 months)
- Progression-free survival(From the date of disease recurrence until the date that local and/or distant progression of disease occurs, assessed up to 18 months)
- Local progression-free survival(From the date of disease recurrence until the date that locoregional progression of disease occurs, assessed up to 18 months)
研究者
Martijn P.W. Intven
Principal Investigator
UMC Utrecht