None listed
Conditions
Brief summary
The purpose of this study is to compare the immune responses within cancer tumours which have and have not been treated with stereotactic ablative body radiotherapy (SBRT). Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have cancer in the head or neck regions. Study details All patients undergo SBRT to tumour sites, which delivers a high dose of radiotherapy to the tumour. This will occur across 1-8 treatment sessions (fractions), and most likely 3-5 fractions for one tumour site, and one fraction will be given each day over 30 minutes. Depending on the tumour site, fractions can be given on consecutive weekdays or every 2nd weekday. Your treatment sessions will depend on the number of tumour sites that the doctor considers can be safely treated with SBRT. Before and after SBRT, there will be PET imaging using novel tracer 89Zr-Df-IAB22M2C to track immune cells in the tumour and in the whole body. Blood tests will also be performed before and after SBRT. It is hoped that this research will provide information on how to best deliver immunotherapy with SBRT radiotherapy, thus improving treatment of head and neck cancer.
Interventions
Eligible study participants will be treated with stereotactic ablative radiotherapy (SBRT) at the department of Radiation Oncology. SBRT is the standard of care for patients with limited areas of progressive disease. The process of the radiotherapy includes simulation, radiation planning and delivery.
During the simulation, all patients will undergo CT and MR of the region of interest encompassing the disease to be treated. Patient’s positioning and immobilisation device will also be determined
Eligible study participants will be treated with stereotactic ablative radiotherapy (SBRT) at the department of Radiation Oncology. SBRT is the standard of care for patients with limited areas of progressive disease. The process of the radiotherapy includes simulation, radiation planning and delivery. During the simulation, all patients will undergo CT and MR of the region of interest encompassing the disease to be treated. Patient’s positioning and immobilisation device will also be determined. Based on planning CT and MRI, the gross tumour volume, the number of the oligo-progressive sites that can be treated and targetable with SBRT will be determined by one of the investigators (consultant radiation oncologists). Dose and fractions will be prescribed according to the tumour site, total radiation dose may span from 16 to 60 grays, the number of fractions can be between 1 and 8, and the dose for each treatment session (fraction) will be between 6 to 34 grays. SBRT will be delivered by 2 qualified and experienced radiotherapists. One fraction will be delivered each day, the total dose will be given on consecutive weekdays or every 2nd day. The PET scan will be done at Austin PET centre, the department is well equipped and is able to generate 89Zr labelled antibodies. The radiotracer will be administered via IV injection, and the scan will take 60 to 90 minutes.
Sponsors
Olivia Newton-John Cancer Research Institute (ONJCRI)
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
head and neck SCC with oligo-progression to 1-10 extracranial lesions, lesion size no more than 5cm and involving no more than 3 organs. Sites of oligo-progressive disease can be targetable with SBRT and safely treated At least one tumour lesion can be observed and will not be in the beam path of SBRT, and the observed lesion must be measurable by the criteria of RECIST version 1.1
Exclusion criteria
Metastatic or locoreginal disease disease invades the GI tract or large blood vessels
Outcome results
None listed