Clinical trial · Interventional
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
NCT00609284CI-TRIAL-000446612007-01completedPhase 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 aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy 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 |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin, 5FU concomitant | Drug | — | UNRESOLVED |
| cetuximab | Drug | Cetuximab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Radiotherapy 70Gy, Erbitux, Carboplatin-5FU
- interventionNames
- Drug: cetuximab
- Drug: Carboplatin, 5FU concomitant
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Radiotherapy 70Gy, Erbitux
- interventionNames
- Drug: cetuximab
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx * Stage III - IV (T0-T4, N0-N2b, M0) * Not resected * Karnofsky PS\>=80 * Informed consent signed Exclusion Criteria: * Contra indication to chemotherapy or cetuximab
References
Publications (0)
Data not yet available
No reference posted for this study.