Clinical trial · Interventional
TRACE: Tirapazamine-Radiation And Cisplatin Evaluation
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
NCT00174837CI-TRIAL-00022390TRACEcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Tirapazamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tirapazamine + Cisplatin
- interventionNames
- Drug: Tirapazamine
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin
- interventionNames
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Study period
Secondary outcomes (4)
- measure
- Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. * Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease). * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * Absolute neutrophil count at least 1.5 X 10\^9/L, platelet count at least 100 X 10\^9/L, and hemoglobin \> 9g/dL. * Serum bilirubin \< 1.25 times upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) \< 2.5 times ULN. * Calculated creatinine clearance (Cockcroft-Gault) \> 55 mL/min. Exclusion Criteria: * Metastatic Disease * Primary cancers of the nasal and paranasal cavities and of the nasopharynx * Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial * Symptomatic peripheral neuropathy \> grade 2 * Clinically significant hearing impairment * Significant cardiac disease
References
Publications (0)
Data not yet available
No reference posted for this study.