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
- Conditions
- Oncology: Advanced Head and Neck cancerMedDRA version: 7.0Level: LLTClassification code 10025960
- Registration Number
- EUCTR2004-002017-37-HU
- Lead Sponsor
- Sanofi-Synthelabo Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
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
ECOG>2
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 entering the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary endpoints: Failure free survival, time to locoregional failure, patterns of failure, toxicity and safety, Initial response rates, final CR, change in QOL, percent of patients who are feeding tube dependent 12 months after completion of therapy;Primary end point(s): Primary endpoint: Overall Survival;Main Objective: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin, and radiation versus cisplatin and radiation.<br>Primary endpoint: Overall Survival
- Secondary Outcome Measures
Name Time Method