Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
INTERCEPTOR
1 other identifier
interventional
282
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2009
Longer than P75 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
October 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 5, 2017
September 1, 2017
7.3 years
October 16, 2009
September 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
5 years
Secondary Outcomes (4)
Incidence of acute and late toxicities in the two arms
5 years
Progression free survival
5 years
Locoregional control
5 years
Response rate
5 years
Study Arms (2)
ARM A
EXPERIMENTALInduction chemotherapy: TCF (Vermorken, N Eng J Med 2007) Definitive treatment: RT + C-mab (Bonner, N Eng J Med 2006)
ARM B
ACTIVE COMPARATORRT + Cddp (RTOG, Adelstein, J Clin Oncol 2003)
Interventions
docetaxel 75 mg/sqm day1 cisplatin 75 mg/sqm day1 5-fluorouracil 750 mg/sqm/d c.i. day1 to day4 q21
Conformal radiotherapy or IMRT should be employed. Standard radiotherapy: Minimum radiation dose 70 Gy. Additional boost up to 10 Gy if clinically indicated.
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, 100 mg/sqm every 3 weeks, three times, concurrent with RT, starting from day 1 of treatment.
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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, 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
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
Related Publications (10)
- J.P. Pignon et al. Lancet 2000
RESULT- A. Forastiere et al., New Engl J Med 2001
RESULT- Adelstein DJ J.Clin.Oncol. 2003
RESULT- Henke, New England 2004
RESULT- J.A. Bonner et al., New Engl J Med 2006
RESULTMerlano 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.
PMID: 16476835RESULT- Posner M et al, New Engl J Med 2007
RESULT- Vermorken J et al, New Engl J Med 2007
RESULT- Lo Nigro, Journal of Cancer Research Clinical Oncology 2009
RESULTMerlano 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.
PMID: 12927569RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MARCO MERLANO, MD
ASCO, ESMO, AIOM, G.O.N.O.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 16, 2009
First Posted
October 22, 2009
Study Start
September 1, 2009
Primary Completion
December 31, 2016
Study Completion
December 1, 2021
Last Updated
September 5, 2017
Record last verified: 2017-09