Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC
NCT ID: NCT01874171
Last Updated: 2017-05-08
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
334 participants
INTERVENTIONAL
2012-11-15
2019-02-28
Brief Summary
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Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing platinum-based compounds) in head and neck cancer, but is potentially less toxic.
Results of this trial will be used to determine the optimum treatment of this debilitating cancer, with the primary aim of decreasing toxicity and improving quality of life for HPV+OPSCC patients.
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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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Cisplatin
Three doses of cisplatin 100mg/m2 given at days 1, 22 and 43 from start of radiotherapy.
Cisplatin
Cetuximab
Initial dose of 400mg/m2 one week before start of radiotherapy followed by seven weekly doses of 250 mg/m2 during radiotherapy.
Cetuximab
Interventions
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Cisplatin
Cetuximab
Eligibility Criteria
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Inclusion Criteria
* Clinical multidisciplinary team decision to treat with primary curative cisplatin chemoradiotherapy
* No previous treatment including surgery, except node biopsies or diagnostic tonsillectomy
* Medically fit (ECOG 0, 1 or 2)
* Adequate cardiovascular, haematological, renal and hepatic function
* Age \> 18 years
* Written informed consent given
* Using adequate contraception \[male and female participants\]. Must take contraceptive measures during, and for at least six months after treatment.
Exclusion Criteria
* AJCC TNM Stage T1-2N0 disease
* Treated with primary radical surgery to the primary site (e.g. resection)
* Concurrent use of CYP3A4 inducers or inhibitors. \[A standard course of dexamethasone or aprepitant for the prevention of cisplatin-induced nausea and vomiting is permitted\]
* Serious cardiac illness or other medical conditions precluding the use of cisplatin or cetuximab \[no history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities; no uncontrolled seizure disorder; no active neurologic disease; no neuropathy greater than grade 1\]
* Patients who have p16+ tumours who also have N2b, N2c or N3 nodal disease and whose lifetime smoking history is also more than 10 pack years (i.e. have both risk factors).
* Pregnant or lactating
* Previous treatment for any other cancer with cytotoxics, radiotherapy or anti-EGFR therapies
* Inadequate renal, haematological or liver functions \[Absolute neutrophil count \<1,500/mm3; platelet count \<100,000/mm3; WBC \<3,000/mm3; haemoglobin \<9 g/dL. \[Haemoglobin correction by transfusion permitted.\] Bilirubin \> 1.5 times upper limit of normal (ULN); alkaline phosphatase \> 2.5 times ULN; AST and ALT \> 2.5 times ULN. Creatinine \> 1.5 mg/dL; Creatinine clearance \< 60 mL/min\]
* Patients with clinically significant hearing impairment
* Life expectancy less than 3 months
* Other malignancy within the past 3 years except basal cell skin cancer or pre-invasive carcinoma of the cervix.
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
University of Birmingham
OTHER
University of Oxford
OTHER
University of Warwick
OTHER
Responsible Party
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Prof. Janet Dunn
Professor of Clinical Trials
Principal Investigators
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Hisham Mehanna, PhD, BMedSc (hons), FRCS
Role: STUDY_CHAIR
University of Birmingham
Locations
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St Luke's Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
VU University Medical Center
Amsterdam, , Netherlands
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Clatterbridge Cancer Centre
Bebington, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Cheltenham General Hospital
Cheltenham, , United Kingdom
Colchester General Hospital
Colchester, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Queen Elizabeth Hospital Birmingham
Edgbaston, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
St James's Institute of Oncology
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
University College Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
New Cross Hospital
New Cross, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Norfolk & Norwich University Hospital
Norwich, , United Kingdom
Nottingham University Hopsital
Nottingham, , United Kingdom
Glan Clwyd Hospital
Rhyl, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Countries
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Related Links
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De-ESCALaTE study website
Other Identifiers
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2011-005165-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISRCTN33522080
Identifier Type: OTHER
Identifier Source: secondary_id
RMRCT0034
Identifier Type: -
Identifier Source: org_study_id
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