Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
NCT ID: NCT00999700
Last Updated: 2017-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
282 participants
INTERVENTIONAL
2009-09-30
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ARM A
Induction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
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
radiotherapy
Conformal radiotherapy or IMRT should be employed.
Standard radiotherapy:
Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
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
ARM B
RT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
cisplatin
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
radiotherapy
Conformal radiotherapy or IMRT should be employed.
Standard radiotherapy:
Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
Interventions
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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
radiotherapy
Conformal radiotherapy or IMRT should be employed.
Standard radiotherapy:
Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
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
cisplatin
Cisplatin, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
radiotherapy
Conformal radiotherapy or IMRT should be employed.
Standard radiotherapy:
Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Gruppo Oncologico del Nord-Ovest
OTHER
Responsible Party
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MARCO MERLANO
MD
Principal Investigators
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MARCO MERLANO, MD
Role: PRINCIPAL_INVESTIGATOR
ASCO, ESMO, AIOM, G.O.N.O.
Locations
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Ospedale S. Giacomo
Novi Ligure (al), Italy, Italy
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Rionero in Vulture (pz), Italy, Italy
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
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
Milan, , Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, , Italy
Azienda Ospedaliero-Universitaria Di Parma
Parma, , Italy
Azienda Ospedaliera Ospedali Riuniti Di Fano
Pesaro, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , 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
Countries
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References
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- 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.
- 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.
Related Links
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click on "trials" for more informations
Other Identifiers
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EUDRACT NUMBER 2009-013402-14
Identifier Type: -
Identifier Source: org_study_id
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