Clinical trial · Interventional
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced 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)
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in 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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Accelerated fraction radiotherapy with concomitant boost | Radiation | — | UNRESOLVED |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Hydroxyurea | Drug | Hydroxyurea | ALIAS |
| Twice-daily radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: Cetuximab+FHX
- description
- Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
- interventionNames
- Drug: Cetuximab
- Drug: 5-FU
- Drug: Hydroxyurea
- Radiation: Twice-daily radiation
- type
- EXPERIMENTAL
- label
- B: Cetuximab + PX
- description
- Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
- interventionNames
- Drug: Cetuximab
- Drug: Cisplatin
- Radiation: Accelerated fraction radiotherapy with concomitant boost
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Stage III and IV head and neck cancer * Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area * No prior chemotherapy or radiotherapy * Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Normal organ and marrow function Exclusion Criteria: * Unequivocal demonstration of metastatic disease * Known severe hypersensitivity to drugs used in the study * Treatment with a non-approved or investigational drug within 30 days before Day 1 * Incomplete healing from previous surgery * Pregnancy or breast feeding * Uncontrolled intercurrent illness including * Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF * Acute hepatitis or known HIV * Severe baseline neurologic deficits * Prior therapy which specifically and directly targets the EGFR pathway * Prior severe infusion reaction to a monoclonal antibody
References
Publications (0)
Data not yet available