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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002017-37-HU

Enrollment

550

Registered

2005-01-21

Start date

2005-03-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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. Primary endpoint: Overall Survival	—

Measure

Time frame

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. Primary endpoint: Overall Survival

—

Countries

Belgium, Germany, Hungary, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026