magnetic resonance imaging (mri) guided stereotactic adaptive radiotherapy for targeting abdominal cancer

Conditions: Abdominal Cancer

Summary: 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.

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. aim 3: explore functional mri biomarkers of radiotherapy response prediction. candidate functional biomarkers of tumour perfusion and diffusion will be identified.

Eligibility criteria:
inclusion criteria: * 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: 1. liver 2. adrenal 3. abdomino-pelvic lymph node 4. other abdominal site e.g. pancreatic, renal. 5. other pelvic site 6. 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. or * 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 exclusion criteria: * 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