Phase III randomized trial of concomitant radiation, cisplatin, and tirapazamine (SR259075) versus concomitant radiation and cisplatin in patients with advanced head and neck cancer - TRACE

Sanofi-Synthelabo Research0 个研究点目标入组 550 人开始时间: 2005年4月13日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
•Stage III or IV disease (excluding T1N1, T2N1 and metastatic disease)
•The disease must be considered to be potentially curable by combined chemoradiation
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Non adequate renal, hepatic or hematologic function
•Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy during the trial such as HIV infection, cardiac insufficiency, pulmonary compromise, active alcohol abuse, active infection or febrile illness
•History of myocardial infarction, history of ventricular arrhytmias, angina or active coronary heart disease within 6 months, active peripheral claudition within 6 months
•Primary cancers of the nasal and paranasal cavities and of the nasopharynx
•Distant metastasis
•Prior systemic chemotherapy for cancer
•Prior radiation for head and neck cancer
•prior experimental therapy for cancer within 30 days of entereing the trial

发起方

Sanofi-Synthelabo Research