Status:
UNKNOWN
Induction Chemotherapy Followed by Cetuximab Plus Definitive Radiotherapy Versus Radiation Plus Cisplatin
Lead Sponsor:
Gruppo Oncologico del Nord-Ovest
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 (HN...
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, Adels...
Eligibility Criteria
Inclusion
- \> 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00999700
Start Date
September 1 2009
End Date
December 1 2021
Last Update
September 5 2017
Active Locations (21)
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1
Ospedale S. Giacomo
Novi Ligure (al), Italy, Italy
2
Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)
Rionero in Vulture (pz), Italy, Italy
3
Ospedale Civile Ss. Antonio E Biagio
Alessandria, Italy
4
Ausl Della Valle D' Aosta
Aosta, Italy