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Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC (De-ESCALaTE)

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ClinicalTrials.gov Identifier: NCT01874171
Recruitment Status : Unknown
Verified May 2017 by Prof. Janet Dunn, University of Warwick.
Recruitment status was:  Active, not recruiting
First Posted : June 10, 2013
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
Cancer Research UK
University of Birmingham
University of Oxford
Information provided by (Responsible Party):
Prof. Janet Dunn, University of Warwick

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Oropharyngeal Squamous Cell Carcinoma Drug: Cisplatin Drug: Cetuximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

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


Outcome Measures
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Primary Outcome Measures :
  1. Compare severe (acute and late) toxicity (Grade 3-5) caused by cetuximab and radiotherapy to that caused by cisplatin and radiotherapy. [ Time Frame: Up to two years after end of treatment. ]

Secondary Outcome Measures :
  1. Overall number of events of acute severe toxicity between treatment arms. [ Time Frame: Up to and including three months after end of treatment. ]
  2. Overall number of events of late severe toxicity between treatment arms. [ Time Frame: From three months up to two years after end of treatment. ]
  3. Quality of life outcomes assessed by EORTC QLQ C30 and HN35 between the two treatment arms. [ Time Frame: Baseline, end of treatment, and 3, 6, 12 & 24 months after end of treatment. ]
  4. Effect on swallowing of the two treatment arms (assessed by MDADI and by PEG or RIG utilisation rate at 1 and 2 years). [ Time Frame: Baseline, end of treatment, and 3, 6, 12 & 24 months after end of treatment. ]
  5. Cost-effectiveness of the two treatment arms (assessed by EuroQoL-5D). [ Time Frame: Up to two years after end of treatment. ]
    Questionnaires completed at the following time points: Baseline, end of treatment, and 3, 6, 12 & 24 months after end of treatment.

  6. Overall survival and recurrence between the two arms. [ Time Frame: Up to two years after end of treatment. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 six 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874171


Locations
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Sponsors and Collaborators
University of Warwick
Cancer Research UK
University of Birmingham
University of Oxford
Investigators
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Study Chair: Hisham Mehanna, PhD, BMedSc (hons), FRCS University of Birmingham
More Information
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Additional Information:

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Responsible Party: Prof. Janet Dunn, Professor of Clinical Trials, University of Warwick
ClinicalTrials.gov Identifier: NCT01874171    
Other Study ID Numbers: RMRCT0034
2011-005165-21 ( EudraCT Number )
ISRCTN33522080 ( Other Identifier: ISRCTN )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents
Antineoplastic Agents, Immunological