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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||334 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Cisplatin
Three doses of cisplatin 100mg/m2 given at days 1, 22 and 43 from start of radiotherapy.
Initial dose of 400mg/m2 one week before start of radiotherapy followed by seven weekly doses of 250 mg/m2 during radiotherapy.
- 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. ]
- Overall number of events of acute severe toxicity between treatment arms. [ Time Frame: Up to and including three months after end of treatment. ]
- Overall number of events of late severe toxicity between treatment arms. [ Time Frame: From three months up to two years after end of treatment. ]
- 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. ]
- 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. ]
- 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.
- Overall survival and recurrence between the two arms. [ Time Frame: Up to two years after end of treatment. ]
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
|Study Chair:||Hisham Mehanna, PhD, BMedSc (hons), FRCS||University of Birmingham|