Clinical trial · Interventional
Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Randomized Phase 2 Trial of Tirapazamine and the Role of Tumor Hypoxia in Advanced Squamous Head and Neck Cancer
- 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)
PURPOSE: Randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (RT + cisplatin + 5-FU) with or without tirapazamine for the treatment of patients with stage III or IV squamous cell carcinomas of the head and neck cancer (SCCHN). RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.
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 |
|---|---|---|---|
| Squamous Neck Carcinoma of the Head and Neck Cancer (SCCHN) | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiotherapy (RT) | Radiation | — | UNRESOLVED |
| Tirapazamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tirapazamine + cisplatin + 5-FU
- description
- 2 cycles of induction chemotherapy (tirapazamine, cisplatin, and 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (tirapazamine, cisplatin, and 5-FU)
- interventionNames
- Drug: Tirapazamine
- Drug: Cisplatin
- Drug: 5-fluorouracil
- Radiation: Radiotherapy (RT)
- type
- ACTIVE_COMPARATOR
- label
- Cisplatin + 5-FU
- description
- 2 cycles of induction chemotherapy (cisplatin + 5-fluorouracil \[5-FU\]) followed by simultaneous chemoradiotherapy (cisplatin + 5-FU)
- interventionNames
- Drug: Cisplatin
- Drug: 5-fluorouracil
- Radiation: Radiotherapy (RT)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Biopsy proven squamous cell carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Unknown primary Paranasal sinus Histologically proven poorly-differentiated carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Paranasal sinus Stage III/IV (T0-4 N1-3 M0-2) disease PATIENT CHARACTERISTICS: WBC at least 3,000/mm3 Bilirubin no greater than 2.0 mg/dL AST no greater than 100 U/L Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min (patients in Group N2-N3) No second malignancy within 5 years except curatively treated nonmelanomatous skin carcinoma No prior RT or chemotherapy, except prior radiotherapy to primary tumor allowed Not pregnant or nursing. Negative pregnancy test required Effective contraception required of fertile women Subjects with unknown primary cancers who had metastatic cervical lymph nodes are eligible Signed informed consent previously approved by the Institutional Review Board.
References
Publications (1)
- RESULTLe QT, Taira A, Budenz S, Jo Dorie M, Goffinet DR, Fee WE, Goode R, Bloch D, Koong A, Martin Brown J, Pinto HA. Mature results from a randomized Phase II trial of cisplatin plus 5-fluorouracil and radiotherapy with or without tirapazamine in patients with resectable Stage IV head and neck squamous cell carcinomas. Cancer. 2006 May 1;106(9):1940-9. doi: 10.1002/cncr.21785. PMID 16532436