Clinical trial · Interventional
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multicentre Comparative Study of Gefitinib 250 mg or 500 mg (IRESSA™) Given Either Continuously or Concomitantly With Cisplatin Plus Radiotherapy for the Treatment of Patients With Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
- 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 primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
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 |
|---|---|---|---|
| Neoplasms, Squamous Cell | Squamous Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (7)
- type
- PLACEBO_COMPARATOR
- label
- 1
- description
- Radiation + cisplatin; followed by placebo as maintenance therapy
- interventionNames
- Drug: cisplatin
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- 2
- description
- 250 mg gefitinib + radiation + cisplatin; followed by placebo as maintenance therapy
- interventionNames
- Drug: gefitinib (Iressa)
- Drug: cisplatin
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed stage III or IVA squamous cell carcinoma of the head and neck * No prior surgery or chemotherapy/biological therapy/radiation therapy * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) * Life expectancy of more than 12 weeks Exclusion Criteria: * Cancers of the nasal space, oral cavity and larynx; or certain lung diseases. * Abnormal blood chemistry; uncontrolled respiratory, cardiac, hepatic, or renal disease; or coexisting malignancies.
References
Publications (0)
Data not yet available