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Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin (INTERCEPTOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Gruppo Oncologico del Nord-Ovest
Sponsor:
Information provided by (Responsible Party):
MARCO MERLANO, Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier:
NCT00999700
First received: October 16, 2009
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Drug: docetaxel - cisplatin - 5-fluorouracil
Radiation: radiotherapy
Drug: cetuximab
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin

Resource links provided by NLM:


Further study details as provided by Gruppo Oncologico del Nord-Ovest:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of acute and late toxicities in the two arms [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Locoregional control [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 278
Study Start Date: September 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM A
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
Drug: docetaxel - cisplatin - 5-fluorouracil
docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21
Radiation: radiotherapy

Conformal radiotherapy or IMRT should be employed.

Standard radiotherapy:

Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

Drug: cetuximab
400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment
Active Comparator: ARM B
RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
Drug: cisplatin
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
Radiation: radiotherapy

Conformal radiotherapy or IMRT should be employed.

Standard radiotherapy:

Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999700

Contacts
Contact: MARCO MERLANO, MD +390171616739 ext 6739 MERLANO.M@OSPEDALE.CUNEO.IT
Contact: IDA COLANTONIO, MD +390171616739 ext 6739 COLANTONIO.I@OSPEDALE.CUNEO.IT

Locations
Italy
Ospedale Civile Ss. Antonio E Biagio Recruiting
Alessandria, Italy
Contact: FULVIA BLENGIO, MD    +39 0131 ext 206753    fblengio@ospedale.al.it   
Contact: MAURA ROSSI, MD    +39 0131 ext 206753    mrossi@ospedale.al.it   
Principal Investigator: FULVIA BLENGIO, MD         
Sub-Investigator: MAURA ROSSI, MD         
Ausl Della Valle D' Aosta Recruiting
Aosta, Italy
Contact: GIANMAURO NUMICO, MD       gnumico@ausl.vda.it   
Principal Investigator: GIANMAURO NUMICO, MD         
Policlinico S. Orsola-Malpighi Recruiting
Bologna, Italy
Contact: CARMINE PINTO, MD       carmine.pinto@aosp.bo.it   
Contact: FRANCESCA DI FABIO, MD       francesca.difabio@aosp.bo.it   
Principal Investigator: CARMINE PINTO, MD         
Sub-Investigator: FRANCESCA DI FABIO, MD         
A.S.O. S. Croce E Carle Recruiting
Cuneo, Italy, 12100
Contact: MARCO MERLANO, MD    +390171616739 ext 6739    MERLANO.M@OSPEDALE.CUNEO.IT   
Contact: IDA COLANTONIO, MD    +390171616739 ext 6739    COLANTONIO.I@OSPEDALE.CUNEO.IT   
Principal Investigator: MARCO C MERLANO, MD         
Sub-Investigator: NERINA DENARO, MD         
Irccs - Aou S. Martino - Oncology Recruiting
Genoa, Italy
Contact: STEFANIA VECCHIO, MD    + 39 010 5600 ext 383    stefania.vecchio@hsanmartino.it   
Contact: ALMALINA BACIGALUPO, MD    +39 010 5600 ext 425    almalina.bacigalupo@hsanmartino.it   
Principal Investigator: PAOLO PRONZATO, MD         
Sub-Investigator: STEFANIA VECCHIO, MD         
Irccs - Aou San Martino - Radiotherapy Recruiting
Genoa, Italy
Contact: ALMALINA BACIGALUPO, MD    +39 0105600 ext 425    almalina.bacigalupo@hsanmartino.it   
Contact: STEFANIA VECCHIO, MD    +39 0105600 ext 383    stefania.vecchio@hsanmartino.it   
Principal Investigator: RENZO CORVO', MD         
Sub-Investigator: ALMALINA BACIGALUPO, MD         
Asl 3 Genovese Recruiting
Genova, Italy
Contact: LUCIANO CANOBBIO, MD       Luciano.Canobbio@asl3.liguria.it   
Contact: MONICA BOITANO, MD       monica.boitano@libero.it   
Principal Investigator: LUCIANO CANOBBIO, MD         
Sub-Investigator: MONICA BOITANO, MD         
E.O. Ospedali Galliera Recruiting
Genova, Italy
Contact: ANDREA GRIMALDI, MD    +39 010 5634 ext 840    andrea.grimaldi@galliera.it   
Contact: MAURO D'AMICO, MD    +39 010 5634 ext 212    mauro.d.amico@galliera.it   
Principal Investigator: ANDREA GRIMALDI, MD         
E.O. Ospedali Galliera Recruiting
Genova, Italy
Contact: ROBERTO D'AMICO, MD    +39 0105634 ext 212    mauro.d.amico@galliera.it   
Contact: DANIELA BRANCHI, MD    +39 0105634 ext 212    sara.campora@galliera.it   
Principal Investigator: ROBERTO D'AMICO, MD         
Azienda Ospedaliera Villa Scassi - Asl3 Recruiting
Italy, Italy
Contact: MANLIO MENCOBONI, MD         
Principal Investigator: MANLIO MENCOBONI, MD         
Aou San Paolo Recruiting
Milano, Italy
Contact: DARIS FERRARI, MD         
Principal Investigator: DARIS FERRARI, MD         
Istituto Nazionale Dei Tumori Recruiting
Milano, Italy
Contact: LISA LICITRA, MD       lisa.licitra@istitutotumori.mi.it   
Contact: CARLO RESTEGHINI, MD       carlo.resteghini@istitutotumori.mi.it   
Principal Investigator: LISA LICITRA, MD         
Sub-Investigator: CARLO RESTEGHINI, MD         
Azienda Ospedaliero Universitaria Di Modena Recruiting
Modena, Italy
Contact: GABRIELE LUPPI, MD         
Contact: ROBERTA DE PENNI, MD       robertadepenni@yahoo.it   
Principal Investigator: GABRIELE LUPPI, MD         
Sub-Investigator: ROBERTA DE PENNI, MD         
Ospedale S. Giacomo Recruiting
Novi Ligure (al), Italy
Contact: BRUNO CASTAGNETO, MD         
Principal Investigator: BRUNO CASTAGNETO, MD         
Azienda Ospedaliero-Universitaria Di Parma Recruiting
Parma, Italy
Contact: SIMONA BUI, MD         
Sub-Investigator: SIMONA BUI, MD         
Azienda Ospedaliera Ospedali Riuniti Di Fano Recruiting
Pesaro, Italy
Contact: RODOLFO MATTIOLI, MD       rodolfo.mattioli@ospedalimarchenord.it   
Contact: LUCA IMPERATORI, MD       lucaimpe@libero.it   
Principal Investigator: RODOLFO MATTIOLI, MD         
Sub-Investigator: LUCA IMPERATORI, MD         
Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: CORRADO BONI, MD       boni.corrado@asmn.re.it   
Contact: GIOVANNA STRIDI, MD       stridi.giovanna@asmn.re.it   
Principal Investigator: CORRADO BONI, MD         
Sub-Investigator: GIOVANNA STRIDI, MD         
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob) Recruiting
Rionero in Vulture (pz), Italy
Contact: MICHELE AIETA, MD    +39 0972 726255    aietamichele@libero.it   
Principal Investigator: MICHELE AITEA, MD         
Ospedale S. Filippo Neri Recruiting
Roma, Italy
Contact: GIAMPIETRO GASPARINI, MD       g.gasparini@sanfilipponeri.roma.it   
Principal Investigator: GIAMPIETRO GASPARINI, MD         
Sub-Investigator: MARIO R D'ANDREA, MD         
Ospedale S. Paolo Recruiting
Savona, Italy
Contact: MARCO BENASSO, MD       m.benasso@asl2.liguria.it   
Contact: VIVIANA VIGO, MD       v.vigo@asl2.liguria.it   
Principal Investigator: MARCO BENASSO, MD         
Sub-Investigator: VIVIANA VIGO, MD         
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Recruiting
Turin, Italy
Contact: UMBERTO RICARDI, MD    +39 011 670 ext 5352    umberto.ricardi@unito.it   
Contact: MARIO AIROLDI, MD    +39 011 633 ext 4134    airoldim@yahoo.com   
Principal Investigator: UMBERTO RICARDI, MD         
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to) Recruiting
Turin, Italy
Contact: MARIO AIROLDI, MD    +39 011 633 ext 4134    airoldim@yahoo.com   
Contact: ROBERTO BERARDO, MD    +39 011633 ext 4134    rberardo@molinette.piemonte.it   
Principal Investigator: MARIO AIROLDI, MD         
Sub-Investigator: ROBERTO BERARDO, MD         
Sponsors and Collaborators
Gruppo Oncologico del Nord-Ovest
Investigators
Principal Investigator: MARCO MERLANO, MD ASCO, ESMO, AIOM, G.O.N.O.
  More Information

Additional Information:
No publications provided

Responsible Party: MARCO MERLANO, MD, Gruppo Oncologico del Nord-Ovest
ClinicalTrials.gov Identifier: NCT00999700     History of Changes
Other Study ID Numbers: EUDRACT NUMBER 2009-013402-14
Study First Received: October 16, 2009
Last Updated: June 18, 2014
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Gruppo Oncologico del Nord-Ovest:
Locally advanced HNSCC
Chemo-radiation
Induction chemotherapy
Stage III/IV
Unresectable disease

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Cisplatin
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014