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Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

Phase 3
18 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

The objective of this trial is to determine whether Cetuximab and radiation preceded by an
induction chemotherapy, may be superior to an established chemoradiation program for HNC
(RTOG regimen, Adelstein DJ J.Clin.Oncol. 2003;21:92-98).

Inclusion Criteria:

- > 18 years of age

- Histologically or cytologically confirmed diagnosis of HNSCC

- Stage III/IV, not suitable for surgery (definitive cure rate improbable, technically
unresectable or medical contraindication for surgery)

- At least one uni-dimensional measurable lesion either by CT scan or MRI

- Signed written informed consents prior to beginning protocol

Specific procedures:

- Tumor tissue available for immunohistochemical staining of EGFR expression and HPV

- Life expectancy of > 3 months at study entry

- ECOG Performance Status of <2 at study entry.

- Effective contraception if risk of conception exists.

- Neutrophils > 2.0/mm³, platelet count > 100,000/mm³, and hemoglobin > 10 g/dl

- Normal liver function

- Serum creatinine > 1.25 x ULN and/or creatinine clearance > 60 ml/min

Exclusion Criteria:

- Prior systemic chemotherapy and/or radiotherapy

- Known peripheral neuropathy > grade 2 NCI-CTC version 3.0

- Known chronic heart failure

- Prior surgery, excluding prior diagnostic biopsy

- Known drug abuse

- Active uncontrolled infection

- Other concomitant anticancer therapy

- Distant metastasis

- Concurrent chronic systemic immune therapy, chemotherapy for disease other than
cancer, or hormone therapy not indicated in the study protocol

- Clinically relevant coronary artery disease or history of a myocardial infarction
within the last 12 months before study entry

- Medical or psychological condition that would not permit the patient to complete the
trial or sign informed consent

- Nasopharyngeal carcinoma WHO type II or III

- Known allergic reaction against any of the components of the treatment

- Pregnancy (absence confirmed by beta-HCG test) or lactation period

- Any prior or on-going investigational medication

- Previous or current malignancy except basal cell carcinoma of the skin or
pre-invasive carcinoma of the cervix

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:



Italy: Ethics Committee

Study ID:

EUDRACT NUMBER 2009-013402-14



Start Date:

September 2009

Completion Date:

March 2015

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Locally advanced HNSCC
  • Chemo-radiation
  • Induction chemotherapy
  • Stage III/IV
  • Unresectable disease
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms