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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
- > 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
Ausl Della Valle D' Aosta
Status: Recruiting
Contact: FULVIA BLENGIO, MD - +39 0131 - fblengio@ospedale.al.it
Aosta, Italy
Policlinico S. Orsola-Malpighi
Status: Recruiting
Contact: GIANMAURO NUMICO, MD - gnumico@ausl.vda.it
Bologna, Italy
A.S.O. S. Croce E Carle
Status: Recruiting
Contact: CARMINE PINTO, MD - carmine.pinto@aosp.bo.it
Cuneo, Italy
Irccs - Aou S. Martino - Oncology
Status: Recruiting
Contact: MARCO MERLANO, MD - +390171616739 - MERLANO.M@OSPEDALE.CUNEO.IT
Genoa, Italy
Irccs - Aou San Martino - Radiotherapy
Status: Recruiting
Contact: STEFANIA VECCHIO, MD - + 39 010 5600 - stefania.vecchio@hsanmartino.it
Genoa, Italy
Asl 3 Genovese
Status: Recruiting
Contact: ALMALINA BACIGALUPO, MD - +39 0105600 - almalina.bacigalupo@hsanmartino.it
Genova, Italy
E.O. Ospedali Galliera
Status: Recruiting
Contact: LUCIANO CANOBBIO, MD - Luciano.Canobbio@asl3.liguria.it
Genova, Italy
E.O. Ospedali Galliera
Status: Recruiting
Contact: ROBERTO D'AMICO, MD - +39 0105634 - mauro.d.amico@galliera.it
Genova, Italy
Azienda Ospedaliera Villa Scassi - Asl3
Status: Recruiting
Contact: ANDREA GRIMALDI, MD - +39 010 5634 - andrea.grimaldi@galliera.it
Italy, Italy
Aou San Paolo
Status: Recruiting
Contact: MANLIO MENCOBONI, MD
Milano, Italy
Istituto Nazionale Dei Tumori
Status: Recruiting
Contact: DARIS FERRARI, MD
Milano, Italy
Azienda Ospedaliero Universitaria Di Modena
Status: Recruiting
Contact: LISA LICITRA, MD - lisa.licitra@istitutotumori.mi.it
Modena, Italy
Ospedale S. Giacomo
Status: Recruiting
Contact: GABRIELE LUPPI, MD
Novi Ligure (al), Italy
Azienda Ospedaliero-Universitaria Di Parma
Status: Recruiting
Contact: BRUNO CASTAGNETO, MD
Parma, Italy
Azienda Ospedaliera Ospedali Riuniti Di Fano
Status: Recruiting
Contact: SIMONA BUI, MD
Pesaro, Italy
Arcispedale S. Maria Nuova
Status: Recruiting
Contact: RODOLFO MATTIOLI, MD - rodolfo.mattioli@ospedalimarchenord.it
Reggio Emilia, Italy
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Status: Recruiting
Contact: CORRADO BONI, MD - boni.corrado@asmn.re.it
Rionero in Vulture (pz), Italy
Ospedale S. Filippo Neri
Status: Recruiting
Contact: MICHELE AIETA, MD - +39 0972 726255 - aietamichele@libero.it
Roma, Italy
Ospedale S. Paolo
Status: Recruiting
Contact: GIAMPIETRO GASPARINI, MD - g.gasparini@sanfilipponeri.roma.it
Savona, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Status: Recruiting
Contact: MARCO BENASSO, MD - m.benasso@asl2.liguria.it
Turin, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
Status: Recruiting
Contact: UMBERTO RICARDI, MD - +39 011 670 - umberto.ricardi@unito.it
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