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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-002017-37-HU
• Date of registration: 21/01/2005
• Prospective Registration: Yes
• Primary sponsor: Sanofi-Synthelabo Research
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 23/03/2005
• Target sample size: 550
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002017-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Germany, Hungary, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Oncology: Advanced Head and Neck cancer
MedDRA version: 7.0 Level: LLT Classification code 10025960

Intervention(s)

Product Name: Tirapazamine
Product Code: SR259075
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Tirapazamine
CAS Number: 27314-97-2
Current Sponsor code: SR259075
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.7-

Product Name: Cisplatin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin

Primary Outcome(s)

Main Objective: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin, and radiation versus cisplatin and radiation.
Primary endpoint: Overall Survival

Primary end point(s): Primary endpoint: Overall Survival

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

Secondary ID(s)

EFC5512