Role of SAMITAL in prevention and treatment of oral mucositis in patients treated with chemo-radiation (CT/RT)for head-and-neck squamous cell carcinomas. A double-blind, Phase 2 placebo controlled, randomized trial. - IOV-HN-1-2012 (ROSAM)

ISTITUTO ONCOLOGICO VENETO0 个研究点目标入组 120 人开始时间: 2012年7月23日最近更新: 2018年2月19日

适应症

试验速览

暂无简介。

•Histologically proven squamous cell carcinomas of the head-and-neck; •primary tumor sites eligible: oral cavity, oropharynx, larynx, hypopharynx; •stage III or IV disease without evidence of distant metastases; •patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemoradiotherapy; •age 18-75 years; •Karnofsky Performance Status =70; •life expectancy =6 months; able to swallow and retain oral medication; •good state of dentation; •patients must be available for treatment and follow-up; •insurance by the patient and/or partner who will use adequate contraception; •signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx; •seroius comorbidities: uncontrolled heart disease, heart failure within 6 months prior to study partecipation, history of serious neurological and/or psychiatric abnormality; •chronic administration of steroids or immunosuppressant; •pregnant female.

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