ACTRN12621001548820尚未招募未知
A Phase 2 study investigating the feasibility of stereotactic ablative body radiotherapy for the palliation of Head and Neck Cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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