MRI-guided adaptive stereotactic radiotherapy for abdominal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Australian-led, multi-center phase 2 randomized trial compares MRI-guided adaptive stereotactic radiotherapy using an MRI-Linac with standard radiotherapy approaches for patients with abdominal oligometastatic or primary liver cancer. Participants are randomized to receive stereotactic ablative body radiotherapy delivered with MRI guidance and adaptive planning to permit dose escalation and improved target coverage. The primary endpoint is 2-year local control of treated lesions, with secondary endpoints including overall survival, toxicity, delivered dose, and targeting accuracy. The study will also explore functional MRI biomarkers of tumor perfusion and diffusion as predictors of radiotherapy response.

Why it matters

Who can join: the full rules

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

Where it's running

• GenesisCare - St Vincent's Sydney
  Darlinghurst, New South Wales, Australia Recruiting
• Austin Health
  Melbourne, Victoria, Australia Not yet recruiting

Study contacts

• Study coordinator: Sukanya Sathyamurthie
• Email: sukanya@gicancer.org.au
• Phone: +61 2 7208 2719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.