Clinical trial · Interventional
Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
NCT00094081CI-TRIAL-00003151completedPhase 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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| Radiation Therapy | Procedure | — | UNRESOLVED |
| tirapazamine (SR259075) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival.
Secondary outcomes (1)
- measure
- Time to locoregional 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). * 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 ULN and AST/ALT \< 2.5 times ULN. * Calculated creatinine clearance (Cockcroft-Gault) \> 55 mL/min. Exclusion Criteria: * Metastatic Disease
References
Publications (1)
- DERIVEDRingash J, Fisher R, Peters L, Trotti A, O'Sullivan B, Corry J, Kenny L, Nuyts S, Wratten C, Rischin D. Effect of p16 Status on the Quality-of-Life Experience During Chemoradiation for Locally Advanced Oropharyngeal Cancer: A Substudy of Randomized Trial Trans-Tasman Radiation Oncology Group (TROG) 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):678-686. doi: 10.1016/j.ijrobp.2016.03.017. Epub 2016 Mar 23. PMID 27209505