A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Rate of local control (Local Response Rate).
研究概览
简要总结
The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on local control, survival, and toxicity in the treatment of oligometastatic cancer to the abdomen.
详细描述
This is an Australian-led multi-centre Phase 2 randomised controlled trial. The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on LC, survival, and toxicity in the treatment of oligometastatic cancer to the abdomen.
This study will provide one of the first high level phase 2 randomised evidence required to demonstrate this new technology improves patient clinical outcomes and inform the selection of patients for MRI-Linac treatment.
The primary objective is to evaluate the effect of MRI-guided adaptive stereotactic radiotherapy on 2 year LC of treated lesion(s) in patients with abdominal oligometastatic or primary liver cancer.
Aim 1: Quantify the effect of MRI-guided stereotactic radiotherapy on patient outcomes. Patient outcomes will be determined by measuring LC, survival, and safety (toxicity).
Aim 2: Quantify patient dose and cancer targeting accuracy. The ability of MRI-Linacs to treat more patients to a higher dose than standard linacs through adaptive dose-escalation and improved target coverage will be quantified. The delivered dose for each treatment arm will be compared.
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
- •Aged 18 years or older
- •Patients with diagnosis of oligometastatic disease from primary colorectal, upper gastrointestinal (e.g. gastric, oesophagus, pancreatic), breast, non-small cell lung, renal cell, or gynaecological malignancy. Oligometastatic disease with controlled primary disease* and maximum total of 5 metastatic lesions in a maximum of 2 different organ systems in any of the following sites:
- •Abdomino-pelvic lymph node
- •Other abdominal site e.g. pancreatic, renal.
- •Other pelvic site
- •Bony or lung is allowed only if in conjunction with an abdominal site above
- •De novo or metachronous oligometastatic disease where the original tumour site has been treated with curative intent.
- •Controlled primary disease in metachronous oligometastastic disease defined as at least 3 months since original tumour treated with curative intent and no progression at primary site
- •Controlled primary disease in de novo oligometastatic disease defined as primary tumour site treated with curative intent and no progression at primary site
- •Oligometastatic disease: Histological confirmation of primary malignancy (histological confirmation of metastasis is not mandatory but should be performed in any situation where there is any diagnostic uncertainty).
- •All oligometastatic sites treatable with SABR.
- •Patients with oligo-progressive / oligo-persistent disease in maximum total of 2 oligo-progressive abdominal metastases and in a maximum 2 different organ systems
- •Visible imaging defined targets and suitable for treatment with SABR
- •Childs Pugh A to B7 (in case of liver treatment)
- •ECOG 0 -2
- •Patient consented
排除标准
- •Contra-indication to MRI
- •Previous high dose radiotherapy to a site requiring stereotactic treatment (including SIRTEX). Further SABR treatment of lesions previously treated with SABR or high dose radiotherapy is not permitted in this trial.
- •Substantial overlap with a previously treated high dose (definitive or stereotactic dose) radiation volume.
- •Primary prostate cancer, carcinoid tumours, germ cell tumours, lymphoma, small cell tumours
- •Pregnant women
- •Complete response of metastatic disease to systemic therapy (i.e. no target for SABR)
- •Competing medical co-morbidity with a more limited prognosis than the cancer diagnosis
研究组 & 干预措施
Intervention: MRI-Linac SABR
The treatment planning protocol follows the UK SABR Consortium Guidelines. Patients will be prescribed the maximum isotoxic dose achievable while meeting normal organ tolerances (normal liver, kidney, spinal cord, stomach, duodenum, small and large bowel, heart, lungs, chest wall). The lowest acceptable SABR doses are indicated in the dose range Table within the protocol. The maximum dose/fraction also indicates the maximum the dose can be escalated to for each adaptive session on the MRI-Linac.
干预措施: Intervention: MRI-Linac SABR (Procedure)
Control: Standard SABR
The treatment planning protocol follows the UK SABR Consortium Guidelines. Patients will be prescribed the maximum isotoxic dose achievable while meeting normal organ tolerances (normal liver, kidney, spinal cord, stomach, duodenum, small and large bowel, heart, lungs, chest wall). The lowest acceptable SABR doses are indicated in the dose range Table within the protocol. The maximum dose/fraction also indicates the maximum the dose can be escalated to for each adaptive session on the MRI-Linac.
结局指标
主要结局
Rate of local control (Local Response Rate).
时间窗: Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy.
To determine if patients treated with MRI guided stereotactic radiotherapy improves local control. Local control is defined as absence of progression in treated lesion(s) and will be measured via clinical progress imaging (and assessed using RECIST criteria).
次要结局
未报告次要终点