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Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC

NCT01874171

Description:

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 considered a distinct disease entity, affecting younger patients and has a good prognosis following treatment. Subsequently, patients can live with the considerable side effects for several decades. 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.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Determination of <span class="go-doc-concept go-doc-intervention">Cetuximab</span> Versus <span class="go-doc-concept go-doc-intervention">Cisplatin</span> Early and Late Toxicity Events in HPV+ OPSCC

Title

  • Brief Title: Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC
  • Official Title: Determination of Epidermal Growth Factor Receptor-inhibitor (Cetuximab) Versus Standard Chemotherapy (Cisplatin) Early And Late Toxicity Events in Human Papillomavirus-positive Oropharyngeal Squamous Cell Carcinoma
  • Clinical Trial IDs

    NCT ID: NCT01874171

    ORG ID: RMRCT0034

    NCI ID: 2011-005165-21

    Trial Conditions

    Oropharyngeal Squamous Cell Carcinoma

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin Cisplatin
    Cetuximab Cetuximab

    Trial Purpose

    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 considered a distinct disease entity, affecting younger patients and has a good
    prognosis following treatment. Subsequently, patients can live with the considerable side
    effects for several decades.

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Cisplatin Active Comparator Three doses of cisplatin 100mg/m2 given at days 1, 22 and 43 from start of radiotherapy. Cisplatin
    Cetuximab Experimental Initial dose of 400mg/m2 one week before start of radiotherapy followed by seven weekly doses of 250 mg/m2 during radiotherapy. Cetuximab

    Eligibility Criteria

    Inclusion Criteria:

    - 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 three months after treatment.

    Exclusion Criteria:

    - 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Severe (acute and late) toxicity (Grade 3-5) caused by cetuximab and radiotherapy to that caused by cisplatin and radiotherapy.

    Secondary Outcome Measures

    Overall number of events of acute severe toxicity between treatment arms.

    Overall number of events of late severe toxicity between treatment arms.

    Quality of life outcomes assessed by EORTC QLQ C30 and HN35 between the two treatment arms.

    Effect on swallowing of the two treatment arms (assessed by MDADI and by PEG or RIG utilisation rate at 1 and 2 years).

    Cost-effectiveness of the two treatment arms (assessed by EuroQoL-5D).

    Overall survival and recurrence between the two arms.

    Trial Keywords