Clinical trial · Interventional
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer
A Phase I/II Trial of ZD1839 (Iressa) Given Concurrently With Cisplatin and Radiotherapy in Patients With Locally Advanced Head and Neck Cancer
NCT00239304CI-TRIAL-00001028completedPhase 1 / Phase 2ClinicalTrials.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)
To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.
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)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Parts 1 and 2: Safety (Incidence of DLTs)
- measure
- Part 3: Safety and tolerability
Secondary outcomes (2)
- measure
- Parts 2 and 3: Efficacy (Incidence of complete response at 3 months after the end of trial treatment based on RECIST criteria)
- measure
- Exploratory Outcome: EGFR-1 expression, amplification and activation Serum VEGF levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed head and neck cancer * Lymph node negative or positive * Metastasis negative * Chemo- and radiotherapy naïve * WHO 0-2 * Measurable disease by RECIST * Written informed consent Exclusion Criteria: * Severe alcohol abuse * Active ILD * Co-existing chronic gastrointestinal disease(s) * Brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.