None listed
Conditions
Brief summary
The purpose of the study is to use a special type of imaging called diffusion weighted MRI, to target “high risk” areas within the tumour for radiation therapy treatment. The area defined by these images will be treated with a boost dose of radiation therapy in addition to the usual radiation treatment offered for your type of cancer. The aim of the study is to increase the dose of radiation therapy given to the tumour to improve the local control of the disease, without worsening the side effects of treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have confirmed cancer of the head and neck region and are not suitable for have surgery or chemotherapy treatments. Study details: This study involves radiation therapy treatment. In addition to the normal procedures which will be required for standard radiation therapy, you will be required to have an extra MRI scan and may need to attend 1-2 extra clinic appointments at the hospital. You will also be asked to complete a questionnaire that will assess your quality of life before, during and after treatment. It is hoped this research will enable previously untreatable head and neck cancers to be more precisely targeted (and thus treated) with radiotherapy.
Interventions
This study aims to assess the feasibility of diffusion weighted magnetic resonance imaging (DW-MRI) guided radiation therapy dose escalation in head and neck cancer (HNC). Participants will need to attend an MRI scan at the Sunshine Coast University Hospital within one week prior to their standard radiotherapy planning CT. This scan will be performed with the participant lying in the radiation therapy treatment position with a custom fit immobilisation mask in place and may take up to an hour to
This study aims to assess the feasibility of diffusion weighted magnetic resonance imaging (DW-MRI) guided radiation therapy dose escalation in head and neck cancer (HNC). Participants will need to attend an MRI scan at the Sunshine Coast University Hospital within one week prior to their standard radiotherapy planning CT. This scan will be performed with the participant lying in the radiation therapy treatment position with a custom fit immobilisation mask in place and may take up to an hour to perform. Based on the quantitative information from this scan, a high-risk volume within the tumour will be identified. A boost dose of 5-7Gy in one fraction will be delivered to this tumour subvolume defined by an area of low apparent diffusion coefficient (ADC) value, representative of increased cellular density. This is followed by a 3-5 day break then the standard fractionated radiation therapy schedule of 66-70Gy over 6-7 weeks is delivered. Each individual treatment takes approximately 15 minutes. The study will be conducted by the Radiation Oncology department at the Sunshine Coast University Hospital in Birtinya, Queensland. The participant will be asked to complete quality of life questionnaires at 5 different timepoints before, during and after the treatment period. These questionnaires may take up to 5mins to complete each time. Patients will be monitored closely by the treating team for any acute or late treatment side effects.
Sponsors
Dr Myo Min
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Histologically confirmed primary squamous cell carcinoma of the head and neck region - Not fit for, or declined surgical resection and/or chemotherapy, or unresectable disease - Able to give informed consent to treatment by understanding the nature, significances and consequences of the study
Exclusion criteria
- Previous radiation therapy to the head and neck region - Evidence of metastatic disease - Contraindication to MRI such as significant claustrophobia, pacemaker/defibrillator or implanted metals - ECOG performance status greater than 2 or KPS less than 60 - Life expectancy likely less than 12 months due to other significant comorbidities - Simultaneous participation in another interventional trial that may interfere with the results of this trial
Outcome results
None listed