NCT05674396招募中2 期
3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
研究概览
简要总结
To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.
详细描述
Objectives:
- To compare local progression-free survival following palliation with SBRT versus traditional fractionations in patients with HN SCC deemed ineligible for curative-intent treatment.
- To compare pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between the treatment modalities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Willing to provide informed consent
- •Histologically confirmed squamous cell carcinoma
- •Primary tumor site in the head and neck (includes oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary gland, and cutaneous subsites as well as tumors of unknown primary site)
- •Ineligible for curative intent treatment after multidisciplinary evaluation (including evaluation by radiation oncologist and surgeon followed by presentation at multidisciplinary tumor board prior to randomization)
- •Prior therapy including radiation, surgery, or systemic therapy is permitted unless further radiation is deemed inappropriate by the enrolling physician
- •Metastatic disease is permitted
排除标准
- •Contraindications to radiotherapy
- •Pregnant or lactating women
- •5.0 PRE-TREATMENT EVALUATION
- •History and physical examination including laryngopharyngoscopy by a radiation oncologist and/or head and neck surgeon within 8 weeks prior to randomization.
- •o Clinical examination will include a detailed description of disease target including measurement where feasible to facilitate response assessment
- •Documentation of smoking history
- •Staging imaging within 12 weeks prior to randomization:
- •Contrast-enhanced CT of the neck and chest or
- •MRI of the neck with CT of the chest or
- •Whole body PET/CT
- •Histological confirmation of squamous cell carcinoma
- •Pregnancy test for women of child-bearing age, within 2 weeks prior to randomization
- •Assessment of all baseline symptoms, using CTCAE version 5.0 within 2 weeks prior to randomization.
- •Assessment of baseline pain score (NRS) and analgesic use (non-opioid and opioid)
- •Completion of QOL scoring within 2 weeks of randomization
- •Informed consents must be obtained prior to any study specific activities
研究组 & 干预措施
Traditional Palliation
Experimental
Participant will be randomized to standard radiation
干预措施: Traditional Palliation (Radiation)
Stereotactic body radiotherapy (SBRT)
Experimental
Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.
干预措施: Stereotactic body radiotherapy (Radiation)
结局指标
主要结局
M. D. Anderson Symptom Inventory - Head & Neck (MDASI-HN) Questionnaires
时间窗: through study completion; an average of 1 year.
M. D. Anderson Symptom Inventory - Head \& Neck (MDASI-HN) score range from 0/10 (0-symptom has not been present)0 to 10 (10-the symptom was as bad as you can imagine it could be)
次要结局
未报告次要终点
研究者
研究点 (2)
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