None listed
Conditions
Brief summary
The main purpose of this study is to investigate the feasibility of Stereotactic Ablative Body Radiation (SABR), a method of delivering palliative radiotherapy, for patients with head and neck cancers. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with either primary head and neck cancer, or another cancer that has metastasized to your head and neck, and you have been assessed as unsuitable for curative-intent surgery and/or radiotherapy by the Head and Neck multidisciplinary team. Study details Participants who choose to enrol in this study will undergo a series of 5 radiotherapy treatment sessions over two weeks, with a minimum of 48 hours between each session. After the treatment sessions your radiation oncologist and the study team will follow up at 3 monthly intervals intervals to examine any side effects, the overall effectiveness and your quality of life. All participants will be assessed at regular intervals post treatment for up to two years. It is hoped this research will provide more knowledge and understanding of the use of SABR in head and neck cancers in Australia. This information may then be used to improve health outcomes for future patients with head and neck cancers
Interventions
Patients will receive multi-fraction Stereotactic Ablative Body Radiation (SABR) 40Gy - 45Gy delivered in 5 fractions over two weeks with a minimum of 48 hours between each fraction. The treatment will be delivered by qualified radiation therapists.
Eligible participants will be prescribed according to the following groups:
-45Gy in 5 fractions (de novo radiation)
-40Gy in 5 fractions (for re-radiation or metastatic cancer)
Participants will be provided with their treatment schedule in advance
Patients will receive multi-fraction Stereotactic Ablative Body Radiation (SABR) 40Gy - 45Gy delivered in 5 fractions over two weeks with a minimum of 48 hours between each fraction. The treatment will be delivered by qualified radiation therapists. Eligible participants will be prescribed according to the following groups: -45Gy in 5 fractions (de novo radiation) -40Gy in 5 fractions (for re-radiation or metastatic cancer) Participants will be provided with their treatment schedule in advance and treatment administration details including duration, staff present, dose delivered etc will be recorded and verified in the electronic patient information system as per standard quality processes.
Sponsors
South Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All participants: 1. Age greater than or equal to 18 years 2. Clinical stage T0-T4, N0-N3, M0 or M1 3. Measurable tumour present in the head and neck region on PET 4. Between 1 and 3 separate high dose PTVs in the head and neck, measuring up to 6 cm each 5. Assessed by a head and neck multidisciplinary team, and deemed unsuitable for curative-intent surgery and / or radiotherapy due to poor performance status, comorbidities, or patient preference 6. ECOG 0-2 7. Life expectancy of at least 6 months 8. Provision of signed and dated informed consent form 9. Stated willingness to comply with all study procedures and availability for the duration of the study Group 1 (de novo radiation) participants: 1. New diagnosis, recurrent, or second primary head and neck cancer with no prior radiotherapy to the region of current active disease 2. Histology or cytology confirming a diagnosis of squamous cell carcinoma (including both mucosal and cutaneous primaries, and all subtypes of nasopharyngeal carcinoma) of the head and neck. Group 2 (reirradiation) participants: 1. Recurrent or second primary head and neck cancer with prior radiotherapy to the region of current active disease 2. Histology or cytology confirming a diagnosis of squamous cell carcinoma (including both mucosal and cutaneous primaries, and all subtypes of nasopharyngeal carcinoma) of the head and neck. Where a biopsy for recurrence is not feasible, the histology or cytology at initial diagnosis is sufficient.At least 6 months between prior radiotherapy and SABR Group 3 (metastatic, non-head and neck primary) participants: 1. Metastatic cancer to the head and neck region from a non-head and neck primary tumour (regardless of radiotherapy naive or reirradiation) 2. All known sites of active cancer in the body can be treated with locally ablative or extirpative therapy (e.g. surgery, radiofrequency ablation, SABR, radical radiotherapy) 3. Up to 5 sites of active cancer in the body (i.e. oligometastatic or oligoprogressive disease)
Exclusion criteria
1. The patient would be better treated with an alternate fractionation schedule according to the treating clinician’s judgement 2. Tumours of the larynx / hypopharynx in the absence of prior laryngectomy 3. Use of cytotoxic chemotherapy or immunotherapy within 3 weeks prior to SABR 4. Histologies other than squamous cell carcinoma 5. Pregnancy 6. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety 7. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
Outcome results
None listed