A study investigating the feasibility of stereotactic radiotherapy for the palliation of Head and Neck Cancer

Not Applicable

• Conditions: Head and Neck Cancer; Cancer - Head and neck

• Registration Number: ACTRN12621001548820
• Lead Sponsor: South Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-15
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients completing the SABR treatment without major protocol violations during treatment delivery and patient compliance assessed by audit of study database on a monthly basis and fortnightly MDT peer review of patients receiving SABR treatment. This is a composite primary outcome.[End of treatment for 40 recruited patients]

Secondary Outcome Measures

Name	Time	Method
Safety outcomes defined as number of participants experiencing minimal toxicities measured by CTCAE v5[Baseline (Pre-treatment), weekly during treatment, 4-6 weeks post treatment and every three months post treatment up to 24 months post treatment.];local progression free survival assessed by CT, MRI or PET scan (RECIST 1.1 scoring) and clinical assessment[3 monthly for up to 24 months post treatment];Overall survival assessed by clinical assessment[24 months post treatment];Time to distant failure assessed by CT, MRI or PET imaging and clinical assessment[3 monthly for up to 24 months post treatment];Quality of life outcomes as measured by FACT-H&N questionnaires [Baseline (Pre-treatment), weekly during treatment, 4-6 weeks post treatment and every three months post treatment up to 24 months post treatment.]