RecruitingACTRN12622000495729

Immune cell distribution change after radiation therapy in patients with advanced head and neck cancer

Stereotactic Ablative Radiotherapy and T Cell Biodistribution for Oligoprogressive Head and Neck Cancer (START-HN)

Sponsor

Olivia Newton-John Cancer Research Institute (ONJCRI)

Enrollment

10 participants

Start Date

May 15, 2024

Study Type

Interventional

Conditions

Oligoprogressive head and neck cancer

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for adults with head and neck cancer whose disease has spread to a limited number of sites (called oligoprogression). It investigates how the immune system responds when tumours are treated with a specialised form of high-precision radiotherapy called stereotactic ablative body radiotherapy, or SBRT. SBRT delivers a concentrated, powerful dose of radiation to the tumour in just a few treatment sessions, which can both shrink the tumour and potentially trigger an immune response against cancer elsewhere in the body. Before and after SBRT treatment, participants will undergo a specialised PET scan using a new imaging agent that tracks immune cells moving through the body and into tumours. Blood tests will also be collected. The aim is to understand how radiation changes the distribution of immune cells and to identify the best way to combine this type of radiotherapy with immunotherapy in the future. You may be eligible if you are 18 or older, have squamous cell carcinoma in the head and neck region with oligoprogression affecting up to ten sites in no more than three organs, each site is no larger than 5 cm, and at least one tumour can be observed without being in the radiation field. People whose disease involves the gut lining or major blood vessels are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. 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.

Locations(1)

VIC, Australia

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ACTRN12622000495729