Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- UMC Utrecht
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- HRQoL deterioration-free survival
研究概览
简要总结
A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC).
详细描述
Rationale: About 40% of patients with pancreatic cancer are diagnosed with locally advanced pancreatic cancer (LAPC). Recommended treatment consists of chemotherapy to prevent disease dissemination and prolong survival. Nevertheless, local tumor growth often causes severe morbidity, including pain, gastrointestinal obstruction, and malnutrition. This has a substantial negative impact on health-related quality of life (HRQoL). Eventually, one-third of patients die due to local tumor growth rather than from systemic disease spread. For palliation of symptoms and improved local tumor control, potentially prolonging survival, minimally-invasive ablative therapies may be effective. Online adaptive stereotactic Magnetic Resonance-guided radiotherapy (MRgRT) is an innovative treatment modality that enables high-precision ablative radiotherapy for pancreatic tumors. This potentially improves RT efficacy without increasing the risk of RT-related toxicity. Consequently, MRgRT holds promise for the treatment of pancreatic cancer.
Objective: To investigate the efficacy of stereotactic MRgRT on HRQoL deterioration-free survival, including death as an event, in patients with LAPC after systemic chemotherapy.
Study design: Nationwide randomized controlled trial (1:1 randomization).
Study population: Patients with LAPC according to Dutch Pancreatic Cancer Group (DPCG) criteria who are not eligible for tumor resection after at least two months of chemotherapy (sample size 150 patients). Also, patients with LAPC who are eligible but choose to refrain from chemotherapy and/or surgery can participate in this trial.
Intervention: Patients in the intervention arm receive 50Gy MRgRT in five fractions over two weeks in one of the four Consortium Centers, followed by standard care, either consisting of continuation of chemotherapy or best supportive care. Patients in the control arm continue standard care without ablative MRgRT.
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
- •Pathology proven pancreatic ductal adenocarcinoma (PDAC);
- •At least two (preferably four) months systemic therapy with (m)FOLFIRINOX and/or gemcitabine + nab-paclitaxel; or eligibility for chemotherapy but no initiation of chemotherapy based on patients' wish;
- •No option for surgical resection, either because anatomical irresectability based on the surgeon's judgement (assessed on imaging or during explorative laparotomy) and/or frailty (unfit for surgery or chemotherapy) and/or no surgery based on patient's wish.
- •No evidence of distant metastatic disease progression, evaluated by CT Thorax / Abdomen / Pelvis and/or PET-CT scan;
- •Performance status WHO 0-2.
排除标准
- •Contra-indications for MRI or CT with an intravenous contrast agent according to the protocol of the local radiology and/or radiotherapy departments
- •Contraindications for MRgRT, as determined by the involved expert radiation oncologists of the Consortium
- •<18 years old
- •Pregnancy
研究组 & 干预措施
Intervention arm
Patients in the intervention arm will receive locally ablative stereotactic MRgRT in addition to standard of care, consisting of 5 times 10 Gy MR guided radiotherapy.
干预措施: MR guided radiotherapy (Radiation)
Control arm
Patients randomized to the control arm will continue standard of care as described without additional local treatment.
结局指标
主要结局
HRQoL deterioration-free survival
时间窗: Through study completion, an average of 18 months
HRQoL deterioration-free survival is defined as the Time Until Definitive Deterioration (TUDD) including death from any cause, calculated from the time of randomization. HRQoL is primarily assessed using the EORTC QLQ-C30 (version 3.0) Summary Score.
次要结局
- Patient reported Quality of Life EORTC QLQ-C30(At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months)
- Patient reported Quality of Life EQ5D-5L(At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months)
- The need of subsequent treatments(Through study completion, an average of 18 months)
- Treatment response assessed on CT-imaging (graded according to RECIST guidelines)(with available imaging during 18 months follow-up)
- Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch(Through study completion, an average of 18 months)
- Trial@home monitoring related outcome: feasibility Body+ scale(Through study completion, an average of 18 months)
- Patient reported Quality of Life EORTC QLQ-PAN26(At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months)
- CA 19.9 response(Through study completion, an average of 18 months)
- Trial@home monitoring related outcome: feasibility ePRO application(Through study completion, an average of 18 months)
- Intervention arm related outcome diffusion weighted images(Through study completion, an average of 18 months)
- Overall survival(From the date of LAPC diagnosis untill either death from any cause or last follow-up, whichever came first, assessed up to 18 months)
- Trial@home monitoring related outcome: digital biomarkers(Through study completion, an average of 18 months)
- Intervention arm related outcome toxicity(Through study completion, an average of 18 months)
- Intervention arm related outcome, completion of therapy(Through study completion, an average of 18 months)
- Trial@home monitoring related outcome: feasibility Whitings Sleep(Through study completion, an average of 18 months)