NL-OMON49128招募中不适用
Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function after Radiotherapy - RESTART
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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)
- •- Use of Beta-blockers (inhibit stem cells growth)
- •- History within the past five years of malignancies other than:
- •o basal or squamous cell carcinoma of the skin
- •o in situ carcinoma of the cervix
- •- Females who are pregnant or lactating at entry
研究者
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