Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
Conditions
Squamous Cell Carcinoma of the Head and Neck
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms
Conditions: Keywords
Locally advanced HNSCC, Chemo-radiation, Induction chemotherapy, Stage III/IV, Unresectable disease
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: docetaxel - cisplatin - 5-fluorouracil Type: Drug
Name: radiotherapy Type: Radiation
Name: cetuximab Type: Drug
Name: cisplatin Type: Drug
Name: radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
A phase III trial of induction chemotherapy followed by definitive radiotherapy plus Cetuximab versus chemoradiation in unresectable, locally advanced, squamous cell carcinoma of the head and neck (HNC).
Detailed Description
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Ospedale Civile Ss. Antonio E Biagio
Alessandria, Italy
Status: Recruiting
Contact: FULVIA BLENGIO, MD - +39 0131 - fblengio@ospedale.al.it
Ausl Della Valle D' Aosta
Aosta, Italy
Status: Recruiting
Contact: GIANMAURO NUMICO, MD - gnumico@ausl.vda.it
Policlinico S. Orsola-Malpighi
Bologna, Italy
Status: Recruiting
Contact: CARMINE PINTO, MD - carmine.pinto@aosp.bo.it
A.S.O. S. Croce E Carle
Cuneo, Italy
Status: Recruiting
Contact: MARCO MERLANO, MD - +390171616739 - MERLANO.M@OSPEDALE.CUNEO.IT
Irccs - Aou S. Martino - Oncology
Genoa, Italy
Status: Recruiting
Contact: STEFANIA VECCHIO, MD - + 39 010 5600 - stefania.vecchio@hsanmartino.it
Irccs - Aou San Martino - Radiotherapy
Genoa, Italy
Status: Recruiting
Contact: ALMALINA BACIGALUPO, MD - +39 0105600 - almalina.bacigalupo@hsanmartino.it
Asl 3 Genovese
Genova, Italy
Status: Recruiting
Contact: LUCIANO CANOBBIO, MD - Luciano.Canobbio@asl3.liguria.it
E.O. Ospedali Galliera
Genova, Italy
Status: Recruiting
Contact: ROBERTO D'AMICO, MD - +39 0105634 - mauro.d.amico@galliera.it
E.O. Ospedali Galliera
Genova, Italy
Status: Recruiting
Contact: ANDREA GRIMALDI, MD - +39 010 5634 - andrea.grimaldi@galliera.it
Azienda Ospedaliera Villa Scassi - Asl3
Italy, Italy
Status: Recruiting
Contact: MANLIO MENCOBONI, MD
Aou San Paolo
Milano, Italy
Status: Recruiting
Contact: DARIS FERRARI, MD
Istituto Nazionale Dei Tumori
Milano, Italy
Status: Recruiting
Contact: LISA LICITRA, MD - lisa.licitra@istitutotumori.mi.it
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Status: Recruiting
Contact: GABRIELE LUPPI, MD
Ospedale S. Giacomo
Novi Ligure (al), Italy
Status: Recruiting
Contact: BRUNO CASTAGNETO, MD
Azienda Ospedaliero-Universitaria Di Parma
Parma, Italy
Status: Recruiting
Contact: SIMONA BUI, MD
Azienda Ospedaliera Ospedali Riuniti Di Fano
Pesaro, Italy
Status: Recruiting
Contact: RODOLFO MATTIOLI, MD - rodolfo.mattioli@ospedalimarchenord.it
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Status: Recruiting
Contact: CORRADO BONI, MD - boni.corrado@asmn.re.it
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Rionero in Vulture (pz), Italy
Status: Recruiting
Contact: MICHELE AIETA, MD - +39 0972 726255 - aietamichele@libero.it
Ospedale S. Filippo Neri
Roma, Italy
Status: Recruiting
Contact: GIAMPIETRO GASPARINI, MD - g.gasparini@sanfilipponeri.roma.it
Ospedale S. Paolo
Savona, Italy
Status: Recruiting
Contact: MARCO BENASSO, MD - m.benasso@asl2.liguria.it
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Turin, Italy
Status: Recruiting
Contact: UMBERTO RICARDI, MD - +39 011 670 - umberto.ricardi@unito.it
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
Turin, Italy
Status: Recruiting
Contact: MARIO AIROLDI, MD - +39 011 633 - airoldim@yahoo.com
Start Date
September 2009
Completion Date
December 2016
Sponsors
Gruppo Oncologico del Nord-Ovest
Source
Gruppo Oncologico del Nord-Ovest
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page