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Status unknownNCT00999700INTERCEPTORUpdated Sep 5, 2017

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

A Phase 3 interventional study of docetaxel - cisplatin - 5-fluorouracil and radiotherapy in Squamous Cell Carcinoma of the Head and Neck, sponsored by Gruppo Oncologico del Nord-Ovest. Status unknown at 21 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by Gruppo Oncologico del Nord-Ovest · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
282
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Squamous Cell Carcinoma of the Head and Neck

Keywords

  • Locally advanced HNSCC
  • Chemo-radiation
  • Induction chemotherapy
  • Stage III/IV
  • Unresectable disease
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In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's planned enrollment of 282 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Gruppo Oncologico del Nord-Ovest is the lead sponsor of 38 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
282 participants (estimated)

Study arms

  • 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 · Radiation: radiotherapy · Drug: cetuximab

  • Active comparator
    ARM B

    RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)

    Drug: cisplatin · Radiation: radiotherapy

Interventions

  • Drugdocetaxel - 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

  • Radiationradiotherapy

    Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

  • Drugcetuximab

    400 mg/sqm at the 1st infusion - before starting RT 250 mg/sqm weekly - concurrent with RT up to the last week of treatment

  • Drugcisplatin

    Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.

  • Radiationradiotherapy

    Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 5 years

Secondary outcomes

  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

07

Study locations

21 sites
  • 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, 12100, Italy
  • 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
08

References and documents

Publications

  • - J.P. Pignon et al. Lancet 2000
  • - A. Forastiere et al., New Engl J Med 2001
  • - Adelstein DJ J.Clin.Oncol. 2003
  • - Henke, New England 2004
  • - J.A. Bonner et al., New Engl J Med 2006
  • Merlano M. Alternating chemotherapy and radiotherapy in locally advanced head and neck cancer: an alternative? Oncologist. 2006 Feb;11(2):146-51. doi: 10.1634/theoncologist.11-2-146. PubMed 16476835 ↗
  • - Posner M et al, New Engl J Med 2007
  • - Vermorken J et al, New Engl J Med 2007
  • - Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
  • Merlano M, Marchetti G. Radiochemotherapy in head and neck cancer. Cancer Treat Rev. 2003 Aug;29(4):291-6. doi: 10.1016/s0305-7372(03)00022-7. PubMed 12927569 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00999700
Lead sponsor
Gruppo Oncologico del Nord-Ovest
Responsible party
MARCO MERLANO (MD, Gruppo Oncologico del Nord-Ovest) — Principal investigator
First posted
Oct 22, 2009
Start date
Sep 2009
Primary completion
Dec 31, 2016
Completion
Dec 2021 (estimated)
Last update
Sep 5, 2017

Study contacts

MARCO MERLANO, MD
principal investigator · ASCO, ESMO, AIOM, G.O.N.O.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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