Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Feasibility: salivary flow rate
研究概览
简要总结
This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Squamous cell carcinoma (SCC) originating from the mucosa of the oral cavity;
- •Primary resection of tumour including an electively or therapeutic ipsilateral neck dissection (at least levels Ib to III, including the submandibular gland).
- •Postoperative radiotherapy or chemoradiation, including prophylactic or therapeutic irradiation of the contralateral side of the neck (where the remaining submandibular gland is), including at least levels Ib to IV), next to irradiation of the tumour bed and ipsilateral neck (current standard);
- •Age ≥ 18 years;
- •WHO performance 0-2;
- •Written informed consent;
排除标准
- •Primary (definitive) radiotherapy, with or without systemic treatment;
- •Previous radiotherapy of the head and neck region (re-irradiation);
- •Positive microbiological screening for Human Immunodeficiency Virus type 1 and 2, hepatitis B and C virus and Treponema pallidum.
- •Presence of systemic disease known to affect salivary gland functioning (e.g., Sjögren's syndrome);
- •Known allergy to mice and gentamicin
- •History within the past five years of malignancies other than:
- •basal or squamous cell carcinoma of the skin
- •in situ carcinoma of the cervix;
- •Females who are pregnant or lactating at entry.
结局指标
主要结局
Feasibility: salivary flow rate
时间窗: Data for assessing feasibility will be recorded 6 and 12 months after autologous stem cell transplantation to assess if salivary flow will be increased compared to salivary flow before transplantation.
The salivary flow rate of the remaining submandibular gland will be recorded.
Safety: adverse events
时间窗: Data for assessing safety will be recorded from day 1 to 365.
The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).
次要结局
- Salivary flow recovery(Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation)
- Impact of transplantation(Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation)
- Overall survival and disease-free survival(5 years after postoperative (chemo)radiation)
- Amount of PSMA(6 and 12 months after autologous stem cell transplantation)
- Locoregional control(5 years after postoperative (chemo)radiation)
- Rate of water diffusion in remaining submandibular gland(6 and 12 months after postoperative (chemo)radiation)