Status:
UNKNOWN
Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC
Lead Sponsor:
University of Warwick
Collaborating Sponsors:
Cancer Research UK
University of Birmingham
Conditions:
Oropharyngeal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection. HPV+OPSCC is considere...
Eligibility Criteria
Inclusion
- American Joint Committee on Cancer (AJCC) TNM Stage III-IVa (T3N0-T4N0, and T1N1-T4N3) oropharyngeal squamous cell carcinoma (SCC) tumours
- 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
- Distant metastasis (i.e. AJCC TNM stage IVc disease)
- 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.
Key Trial Info
Start Date :
November 15 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT01874171
Start Date
November 15 2012
End Date
February 1 2019
Last Update
May 8 2017
Active Locations (33)
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1
St Luke's Hospital
Dublin, Ireland, 6
2
Beaumont Hospital
Dublin, Ireland
3
VU University Medical Center
Amsterdam, Netherlands
4
Aberdeen Royal Infirmary
Aberdeen, United Kingdom