Clinical trial · Interventional
Neoadjuvant Cetuximab in HNSCC Combined With Curative Surgery
Neoadjuvant Cetuximab Monotherapy Followed by Surgery in Squamous Cell Carcinoma of Head and Neck: Phase I/II Study
NCT00714649CI-TRIAL-00008483CHIRONcompletedPhase 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)
Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a minimal delay the time elapsing between last infusion and surgery. Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen profile and protein mutation.
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- I-1
- description
- This is a phase I/II trial. PhaseI: The delay between the last administration of cetuximab and surgery will be progressively reduced. Five delay schedules are pre-defined before final administration of 3 preoperative doses of cetuximab with a 24-hour delay between the last dose of cetuximab and surgery. The cohort size is 3 patients per delay schedule, extended to 6 patients if one "limiting toxicity" is observed. Phase II: will proceed if delay schedule V is safe. The patients included in delay schedule V of the Phase I part of the study will be involved in the phase II analysis. Recruitment of a total of 12 patients (3-6 of delay schedule V in phase I plus an additional 3-9 patients).
- interventionNames
- Drug: cetuximab
Primary outcomes (1)
- measure
- To investigate the safety administration of cetuximab - Phase 1: to determine the safe minimum delay between preoperative cetuximab infusion and surgery -Phase II: to investigate the safety of the minimum delay determined in the phase I part.
- timeFrame
- 10 weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * More than 18 years * Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx * patients selected for a primary surgical treatment * No distant metastases * No active second malignancy during the last 5 years * No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery * life expectancy more than 3 months * Not pregnant or nursing; fertile patients both male or female, must use effective contraception * Signed informed consent * Performance Status ECOG 0-1 Exclusion Criteria: * Nasopharynx cancer * Past or current malignancy other than HNSCC * performance Status ECOG above 2 * Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Use of any investigationals agents within 4 weeks prior ti entry * Previous exposure to EGFR targeting therapy * Known grade hypersensitivity to cetuximab
References
Publications (0)
Data not yet available
No reference posted for this study.