EUCTR2015-001534-13-ES进行中（未招募）1 期
Phase IB-II clinical trial of melatonin oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation.
SPHERIUM BIOMED S.L.0 个研究点目标入组 84 人开始时间: 2015年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female patients 18 years or over.
- •2.Patients who gave written informed consent.
- •3.Life expectancy ? 3 months.
- •4.Histologically confirmed diagnosis of non-metastatic TNM-2010 stage III-IV squamous cell carcinoma of the following sites:
- •ooral cavity
- •ooropharynx or
- •oany Head and Neck site with lymph nodes at cervical level II.
- •5.Histologically confirmed undifferentiated nasopharyngeal carcinoma.
- •6.Patients who have a treatment plan based on systemic treatment (cisplatin or cetuximab) concurrent with radiation with curative intent. Patients may have received up to 3 cycles of neoadjuvant chemotherapy if adverse events related to this treatment are fully resolved before study entry. Patients with a plan of postoperative chemoradiation may be included only if the primary tumour is located in the oral cavity.
- •7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- •8.Adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
- •oHaematology:
- •Absolute neutrophil count (ANC) ?1.5 x 109/L
- •Haemoglobin ? 10 g/dL
- •Platelets ? 100,000 x 109/L
- •Total bilirubin ? 2 X (Upper limit normal) ULN
- •Alanine amino transferase (ALT) and Asparatate aminotransferase (AST) ?5 x ULN
- •For patients who will receive cisplatin: Serum creatinine ? ULN or, if > ULN calculated creatinine clearance (ClCR) ? 60 mL/min.
- •For patients who will receive cetuximab: Serum creatinine <2.0 mg/dl.
- •oNutritional and metabolic:
- •Albumin > 3.0 mg/dl
- •Magnesium > lower limit normal (LLN) for patients who will receive cetuximab
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1.Patients with blistering disease.
- •2.Patients who require feeding with either nasogastric tube, gastrostomy or jejunostomy at study entry
- •3.Patients whose radiotherapy treatment planned dose is lower than 66 Gy
- •4.Patients being receiving another investigational agent because of participation in another therapeutic trial
- •5.Patients treated with fluvoxamine, estrogens, cimetidine, 5- and 8 methoxypsoralen and/or carbamazepine
- •6.Active viral, bacterial or fungal infections of the mouth in the last 14 days (i.e. stomatitis related to herpes virus or candida)
- •7.Pregnancy or lactation
- •8.Known allergy to melatonin
- •9.Prior radiotherapy of the head and neck
- •10.Patients with a treatment plan consisting of chemoradiation followed by further chemotherapy
- •11.Patients with a diagnostics of a synchronic neoplasia except for non-melanoma skin cancer curable with local treatment or in situ cervix carcinoma
- •12.Any investigational agent within 30 days prior to inclusion
- •13.Male or female of childbearing age who do not agree with taking adequate contraceptive precautions, i.e. use contraception double barrier (e.g. diaphragm plus condoms) or abstinence during the course of the study and for 2 months after the last administration of the study drug for women and 1 month for men
- •14.Psychological, geographical, familial or sociological conditions that potentially prevent compliance with the study protocol and follow-up schedule according to investigator criteria. These conditions should be discussed with the patient before inclusion in the trial.
研究者
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