Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00623558

Enrollment

Registered

2008-02-26

Start date

2008-04-30

Completion date

2013-08-31

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasm

Keywords

head and neck neoplasm, cetuximab, docetaxel, cisplatin, radiotherapy

Brief summary

The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.

Interventions

DRUGCetuximab

400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks

DRUGDocetaxel

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

DRUGCisplatin

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Unresectable, locally advanced (cT4b &/or cN2-3) HNSCC * ECOG performance status 0-1 * Age 18 or older than 18 years * Measurable disease by RECIST criteria * Having signed informed consent * ALT and AST\<2.5 times ULN * Serum albumin level ≥3.0g/dL * Serum AKP \< 2.5 times ULN * Bilirubin level \< 1.5mg/dL * Serum creatinine \<1.5 times ULN * WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl

Exclusion criteria

* Previous cytotoxic chemotherapy for HNSCC * Radiotherapy for targeted lesions within six months * Previous EGFR pathway-targeting therapy * Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry) * Distant metastatic disease * Heart failure, coronary artery disease, myocardial infarction within the last 6 months * Known allergy to any study treatment * Pregnancy or lactation period * Any investigational agent within the past 28 days * Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer * Legal incapacity

Design outcomes

Primary

Measure	Time frame
Response rate	after induction treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026