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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999700
Recruitment Status : Active, not recruiting
First Posted : October 22, 2009
Last Update Posted : September 5, 2017
Information provided by (Responsible Party):
MARCO MERLANO, Gruppo Oncologico del Nord-Ovest

Brief 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).

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

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
Study Start Date : September 2009
Actual Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of acute and late toxicities in the two arms [ Time Frame: 5 years ]
  2. Progression free survival [ Time Frame: 5 years ]
  3. Locoregional control [ Time Frame: 5 years ]
  4. Response rate [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999700

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Ospedale Civile Ss. Antonio E Biagio
Alessandria, Italy
Ausl Della Valle D' Aosta
Aosta, Italy
Policlinico S. Orsola-Malpighi
Bologna, Italy
Asl 8 - Ospedale Businco
Cagliari, Italy
A.S.O. S. Croce E Carle
Cuneo, Italy, 12100
Irccs - Aou S. Martino - Oncology
Genoa, Italy
Irccs - Aou San Martino - Radiotherapy
Genoa, Italy
Asl 3 Genovese
Genova, Italy
E.O. Ospedali Galliera
Genova, Italy
Azienda Ospedaliera Villa Scassi - Asl3
Italy, Italy
Istituto Nazionale Dei Tumori
Milano, Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, Italy
Ospedale S. Giacomo
Novi Ligure (al), Italy
Azienda Ospedaliero-Universitaria Di Parma
Parma, Italy
Azienda Ospedaliera Ospedali Riuniti Di Fano
Pesaro, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Rionero in Vulture (pz), Italy
Ospedale S. Filippo Neri
Roma, Italy
Ospedale S. Paolo
Savona, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino Torino (to)
Turin, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Turin, Italy
Sponsors and Collaborators
Gruppo Oncologico del Nord-Ovest
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Principal Investigator: MARCO MERLANO, MD ASCO, ESMO, AIOM, G.O.N.O.

Additional Information:
Publications of Results:
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Responsible Party: MARCO MERLANO, MD, Gruppo Oncologico del Nord-Ovest Identifier: NCT00999700     History of Changes
Other Study ID Numbers: EUDRACT NUMBER 2009-013402-14
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs